Senior Director of Global Regulatory Affairs

Zenas Bio is at the forefront of biopharmaceutical innovation, dedicated to transforming the lives of patients with autoimmune diseases through the development and commercialization of groundbreaking therapies. Our strategic approach leverages a seasoned leadership team and a meticulous product acquisition strategy to identify, acquire, and develop promising…

Zenas BioPharma is a pioneering biopharmaceutical company at the forefront of developing and commercializing transformative therapies for patients suffering from autoimmune diseases. Our strategic approach combines a seasoned leadership team with a rigorous process for acquiring and developing innovative product candidates globally. We are focused on delivering superior clinical benefits to patients affected by autoimmune disorders. We are advancing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab is our lead candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of pathogenic B cells without causing depletion. This innovative therapy offers a self-administered subcutaneous injection regimen, addressing chronic autoimmune diseases effectively. Orelabrutinib, on the other hand, is a highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). We also have promising earlier-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Joining Zenas provides an opportunity to thrive in a dynamic learning environment where individual and organizational success is paramount as we aspire to become a global leader in immunology and autoimmune disease management. Our core values—Transparency, Relationships, Urgency, Excellence, and Innovation—drive us toward TRUE Innovation!Position Summary:As the Senior Manager of Global Quality Assurance for Technical Operations, you will report directly to the Director of Global Quality Assurance for Medical Devices and Combination Products. This strategic role encompasses hands-on quality oversight for late clinical-stage and commercial manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). You will ensure the highest standards of GMP compliance across our global operations, facilitate regulatory submissions and inspections, and drive continuous improvement initiatives alongside internal teams and external manufacturing partners. Your responsibilities will include overseeing batch manufacturing and testing, process validation, and ensuring inspection readiness to maintain robust product quality throughout the development lifecycle.

Zenas Bio is a pioneering clinical-stage global biopharmaceutical organization dedicated to becoming a frontrunner in the development and commercialization of groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic vision combines an accomplished leadership team with a meticulous approach to product candidate acquisition, enabling us to identify, acquire, and develop innovative products worldwide that offer significant clinical benefits to patients living with autoimmune conditions. Zenas is advancing two late-stage potential franchise molecules: obexelimab and orelabrutinib. Obexelimab, our flagship product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, prevalent across B cell lineages, to inhibit the activity of cells implicated in various autoimmune diseases without depleting them. We are confident that obexelimab’s unique mechanism of action and its self-administered, subcutaneous injection regimen can effectively address the pathogenic role of B cell lineages in chronic autoimmune diseases. Orelabrutinib represents a potentially best-in-class, highly selective CNS-penetrant, oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, promising to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our earlier-stage programs also include a preclinical, potentially best-in-class, oral IL-17AA/AF inhibitor and a preclinical, brain-penetrant, oral TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to patients and possess a proven track record in acquiring, developing, and commercializing products on a global scale. Our team members enjoy a dynamic learning environment where they can achieve both individual and organizational success as we strive to become a global leader in immunology and autoimmune disease, while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – the essence of TRUE Innovation!Position Summary:The Director of Regulatory Affairs will lead the daily regulatory activities of early and late-phase investigational products, steering the writing and submission of IND/CTA/amendments and future marketing applications. This role will provide essential guidance to the team on regulatory filings and responses while delivering critical regulatory intelligence back to the team. The Director will collaborate within a cross-functional team, partnering with key internal and external stakeholders, and work alongside Regulatory CMC, Medical Writing, and Regulatory Operations to ensure that scientific data and submissions meet agency expectations in a compliant manner. This position will report directly to the Executive Director of Global Regulatory Affairs.

Join Sobi as the Director of Global Regulatory Advertising and Promotion, where you will lead the development and execution of regulatory strategies for advertising and promotional materials across global markets. Your expertise will ensure compliance with regulatory standards while driving innovative marketing initiatives that resonate with healthcare professionals and patients alike.

About the Role Zenas Bio is looking for a Director of Global Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This leader will guide the company’s quality assurance activities and maintain compliance with regulatory standards. Key Responsibilities Oversee global quality assurance processes related to GCP and GLP. Ensure all practices meet current regulatory requirements and industry standards. Location This position is based in Waltham, MA.

We are seeking a dedicated and dynamic Program Manager to join our team at Integrated Resources, Inc. in Waltham, Massachusetts. As a Program Manager, you will play a crucial role in leading and coordinating various projects, ensuring they are executed efficiently and effectively. Your expertise will help drive our initiatives forward, fostering collaboration across teams and stakeholders.

ElevateBio is a pioneering technology firm that accelerates the advancement of the biotechnology sector by enabling partners to unlock the full potential of their therapies, from conception through to market launch. Our unique combination of cutting-edge technologies, comprehensive services, and top-tier manufacturing expertise allows us to develop advanced therapies more efficiently and effectively.The Role:We are seeking a detail-oriented and analytics-driven CRM Manager to take charge of our HubSpot platform, enhancing both marketing and sales effectiveness. This pivotal role will involve managing marketing automation efforts, ensuring data integrity, and delivering actionable insights that promote revenue growth. The ideal candidate will possess strong technical skills along with a strategic mindset, coupled with a fervent commitment to optimizing processes and empowering teams through proficient CRM utilization.Key Responsibilities:Act as the primary system administrator and expert for the HubSpot platform, overseeing user roles, system configurations, and daily operations to guarantee peak performance.Design, implement, and manage multi-step lead nurturing campaigns and marketing automation workflows in HubSpot, effectively guiding prospects through the buying journey and providing marketing-qualified leads to the sales team.Proactively oversee the health and integrity of the HubSpot database, conducting regular data cleansing, deduplication, and enrichment to maintain the accuracy of all commercial data.Create and manage dashboards and reports to meticulously track and analyze campaign performance, delivering clear insights on open rates, click-through rates, conversion, and pipeline influence to the Director of Commercial Excellence.Develop dynamic and static contact lists to facilitate precise audience segmentation for targeted email campaigns, sales outreach, and event invitations.Collaborate closely with the sales team to develop and refine HubSpot assets that enhance efficiency, including email templates, sales sequences, and lead scoring models that prioritize outreach efforts.Generate comprehensive documentation for HubSpot processes and provide ongoing support and training to sales and marketing teams, ensuring adherence to best practices and fostering platform adoption.

As a Senior Manager of Clinical Data Management at Deciphera Pharmaceuticals, you will lead and oversee the clinical data management function, ensuring high-quality data collection and management practices. You will play a pivotal role in supporting clinical trials through the oversight of data management processes, and collaborate with cross-functional teams to ensure timely and accurate delivery of data for analysis.

Xometry (NASDAQ: XMTR) is at the forefront of transforming industries by bridging innovative minds with manufacturers capable of realizing their visions. Our cutting-edge digital marketplace equips manufacturers with essential resources to expand their businesses, while enabling Fortune 1000 buyers to leverage global manufacturing capabilities effortlessly.We are seeking a dynamic Senior Category Manager based in Boston, Maryland, DC, or Northern Virginia to strategically drive the growth of our Additive business. In this role, you will define and implement comprehensive category strategies, tackle complex challenges, execute tactical initiatives, and monitor key performance indicators. Successful Category Managers will possess exceptional negotiation skills and excel in cross-functional project management.

Role Overview Crescent Biopharma is seeking a Senior Manager or Associate Director of Clinical Data Management based in Waltham, MA. This position leads data management activities for clinical trials, guiding teams to uphold data integrity and meet regulatory requirements. What You Will Do Direct and oversee data management operations for clinical studies. Ensure all processes align with regulatory standards and internal protocols. Work closely with cross-functional partners to improve data collection and analysis methods. Support the development of new therapies by maintaining high-quality clinical data. What Crescent Biopharma Looks For Strategic mindset with strong leadership abilities. Experience managing data in clinical trial settings. Commitment to data accuracy and regulatory compliance. Effective collaboration with diverse project teams.

Join Xometry, a leader in on-demand manufacturing, as a Talent Management Program Manager. In this pivotal role, you will spearhead initiatives to enhance our talent acquisition and development strategies, ensuring we attract and retain top talent in the industry. You will collaborate with various departments to design and implement innovative talent management programs that align with our organizational goals.

At ZoomInfo, we are committed to accelerating careers. We operate with agility, embrace bold ideas, and empower you to achieve your best work. You’ll be part of a team that values deeply caring connections, challenges conventional thinking, and celebrates every success. Our innovative tools enhance your impact, and our culture fosters your ambitions, ensuring you don’t just participate but drive meaningful results at a rapid pace.As a Senior Partnerships Manager, you will play a pivotal role within the ZoomInfo Partnerships Organization, leading the design, implementation, and management of programs that establish a top-tier partner ecosystem aligned with our strategic goals. Your responsibilities will include building and overseeing multiple partner initiatives across various sectors, including Channel Sales, Technology, and Solutions, as we swiftly expand our Partner Ecosystem. We seek a proactive individual who thrives in ambiguity, possesses an entrepreneurial spirit, yet can collaborate effectively within a larger team structure. You will leverage data analysis and qualitative insights to inform your recommendations and are eager to explore innovative solutions. Your proven ability to manage projects end-to-end while engaging with diverse stakeholders will be crucial for delivering outstanding results in a fast-paced, dynamic environment. This position reports directly to the SVP of Partnerships, ensuring that our partner initiatives align with ZoomInfo’s overarching corporate strategy.

We are seeking a highly motivated and skilled Infrastructure Project Manager to lead and oversee various infrastructure projects. In this role, you will be responsible for planning, executing, and closing projects, ensuring they are completed on time and within budget. You will collaborate with various stakeholders, manage project teams, and implement best practices in project management.

Anduril Industries is a pioneering defense technology firm dedicated to enhancing the military capabilities of the U.S. and its allies through innovative technology solutions. By integrating the expertise and business models of the most forward-thinking companies in the 21st century, Anduril is redefining the design, production, and sales processes of military systems. Our suite of products is powered by Lattice OS, an advanced AI-driven operating system that consolidates extensive data streams into a dynamic, 3D command and control center. As we navigate a new era of strategic competition, Anduril is dedicated to delivering breakthrough advancements in autonomy, AI, computer vision, sensor fusion, and networking technology to military operations within months instead of years.ABOUT THE TEAMThe Anduril Imaging team is at the forefront of developing cutting-edge imaging systems, both in hardware and software, designed to address the most pressing security challenges faced by America and its allies. Our team leverages computer vision, perception, electro-optical, infrared, and sensor data to provide our warfighters and allies with a competitive advantage.ABOUT THE JOBThe Senior Production Manager role is a blend of technical expertise and leadership, placing you at the helm of team development and daily operational management for our intricate hardware platforms. Success in this crucial role requires a consistent track record in team management, operational excellence, and achieving financial objectives, ensuring the delivery of mission-critical products of the highest quality.WHAT YOU’LL DOLead Production Operations: Supervise the production of a specific product line, guiding a team of skilled technicians to ensure efficient production and timely delivery of imaging hardware.Drive Daily Production Goals: Strategically plan production schedules to achieve desired performance outcomes while tactically directing daily operations to meet on-time delivery targets.Champion Quality & Safety: Uphold quality and safety standards to minimize defects and promote a secure working environment.Develop & Mentor Talent: Actively coach, mentor, and support production technicians, encouraging professional development and cross-training within the team.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics that aim to revolutionize the treatment of chronic skin diseases. Our mission is to empower patients suffering from conditions like plaque psoriasis with unprecedented freedom from their ailments by achieving complete disease clearance with treatment regimens as infrequent as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies, engineered by Paragon Therapeutics, targeting the fundamental mechanisms behind plaque psoriasis and other dermatological and inflammatory disorders. For more detailed information, please visit www.orukatx.com.As we cultivate our core team, we are in search of exceptional talent across various functional areas—individuals who are not merely seeking a job but are enthusiastic about being part of a larger vision. We seek those who are passionate about making a meaningful impact and are eager to contribute to fostering an engaged, inclusive, and positive company culture.Role Overview:The Clinical Trial Manager/Senior Clinical Trial Manager will be responsible for ensuring compliance with trial protocols, regulatory requirements, and overall trial execution.

At Constant Contact, we pride ourselves on being a team of exceptional individuals who take initiative and make a real difference. With the mindset, integrity, and courage of a small business owner, our work empowers people everywhere to chase their dreams. We play a vital role in supporting business owners, entrepreneurs, non-profits, and individuals by providing the necessary tools and guidance to flourish online. We thrive on new challenges and possibilities, and we're just getting started!We are looking for a Principal Product Manager to spearhead the next generation of our revenue engine. This high-impact strategic position sits at the heart of our mobile-first evolution and AI-driven value delivery. You will lead the way in defining how Constant Contact unlocks enterprise-grade value through innovative monetization frameworks.In this role, you will act as the "Squad Leader" for Monetization, taking full ownership of value. Rather than merely creating payment pages, you will oversee broader strategic monetization levers, including packaging, pricing models, and intelligent cross-sell/up-sell logic. You will connect high-level strategy with relentless execution, driving ARPU expansion and modernizing our revenue engine for a mobile-centric audience.This position exists because we believe that incremental change is insufficient; we are transforming a legacy revenue engine for a mobile-first, AI-powered future.What You’ll DoOwn the Monetization Strategy: Develop comprehensive strategies that go beyond transactional infrastructure to effectively package, price, and sell our value. You will drive ARPU expansion through smart cross-sells, up-sells, and net retention initiatives, managing trials, paywalls, in-product upgrade moments, plan comparisons, expansion paths, downgrades, and renewals.Lead with Velocity: As the Squad Leader for the Monetization team, you will cultivate a culture of autonomy and speed. Transitioning from "output" (shipping features) to "outcomes" (driving revenue and retention), you are empowered to make impactful decisions, conduct rapid experiments, and challenge outdated monetization assumptions to enhance customer value and revenue growth.Drive the Mobile Transformation: With a legacy rooted in desktop, you will transform monetization flows for a mobile-first world, ensuring seamless purchase and upgrade experiences on any device.

How Your Role will Shape Our SuccessJoin Walker Consultants as a dedicated Structural Project Manager to spearhead the design, coordination, and execution of innovative parking structure projects. This position is tailored for a seasoned structural engineer who possesses both advanced technical skills and proficient project management capabilities. The ideal candidate will manage multiple projects, ensuring effective collaboration among clients, architects, and our internal engineering teams while delivering results on time, within budget, and adhering to the highest industry standards.As the Structural Project Manager, you will ensure all structural design and construction elements meet regulatory standards and project specifications. We seek an individual experienced in managing large-scale parking projects, who excels in problem-solving and demonstrates exceptional leadership and communication skills.What Sets Us Apart?Walker is 100% employee-owned! Be a part of a company where your contribution directly impacts our collective success.What makes this opportunity even more appealing is our genuine ownership program. At Walker, our equity-based model empowers shareholders to benefit directly from the firm’s achievements, rather than a conventional ESOP focused solely on stock appreciation. This is a unique opportunity to grow with a company that prioritizes its people.What You’ll Do- Oversee multiple parking structure design projects from initial concept through to construction completion.- Lead structural design initiatives, ensuring adherence to applicable building codes, safety regulations, and industry best practices.- Collaborate with architects, contractors, and consultants to meet project objectives while preserving design integrity.- Partner closely with MEP engineers to guarantee the seamless integration of electrical, mechanical, and plumbing systems within the parking structures.- Manage project timelines, budgets, and resources efficiently.

Xometry is seeking a dynamic and experienced Human Resources Program Manager to join our team in Waltham, MA. In this role, you will be responsible for driving HR initiatives that support our business objectives, enhance employee engagement, and foster a high-performance culture.Your expertise in managing HR programs will be essential in developing strategies to attract, retain, and develop top talent. You will collaborate with various departments to implement best practices in talent management, performance evaluation, and employee development.

Domino's Pizza in Waltham is looking for an Assistant Manager to help keep the restaurant running smoothly. This position plays a key part in supporting daily operations and ensuring customers have a positive experience. Working side by side with the management team, the Assistant Manager helps maintain efficient service throughout each shift. Key responsibilities Supervise restaurant operations during assigned shifts Help train and develop team members Uphold Domino's quality and service standards Assist with problem-solving and team coordination Role focus This role centers on supporting both staff and management. The Assistant Manager steps in to address challenges as they arise and helps keep the team working well together, all while maintaining high standards for food and service.

The Medical Excellence Manager will play a pivotal role in overseeing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP), and Post Trial Access (PTA) Programs. The successful candidate will be tasked with:Managing the ISS review and approval process, ensuring thorough proposal validation, coordination of reviews, and effective communication of decisions to stakeholders.Oversight of the MAP/PTA review and approval process, which includes coordinating case reviews, documenting decisions, and engaging with relevant parties.Acting as the global point of contact for ISS and MAP management concerning specified products, collaborating with cross-functional internal and external stakeholders.Maintaining detailed databases for ISS and MAP/PTA, meticulously tracking proposals, studies, and decisions along with necessary documentation.Facilitating contract development and negotiations between sponsors/requestors and Sobi, working closely with legal and other departments as necessary.Supporting supply chain setup in partnership with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs.Providing regular status updates on ISS and MAP/PTA programs to relevant teams and leadership.Monitoring milestone payments and reporting the ISS budget to budget owners.Coordinating with vendors for the setup and management of MAP and PTA programs as needed.