About the job
As a Regulatory Affairs Manager at AbbVie, you will collaborate closely with your line manager and/or Area Product Lead to implement comprehensive registration strategies that secure regulatory approvals for our commercially successful pharmaceutical products across the European region. You will also ensure effective product maintenance and lifecycle management, aligned with legal and regulatory requirements, as well as regional business needs. Additionally, you may play a pivotal role in supporting the European regulatory strategy for assets currently in development.
Key Responsibilities:
- Collaborate with your line manager and/or Area Product Lead to provide clear, constructive regulatory input and intelligence for the Europe Region, contributing to both Area and Global Regulatory & Development Project Teams.
- Ensure compliance of planned drug development activities with Area guidelines, conducting critical analyses of associated risks and proposing remediation plans when necessary.
- Support the global product development strategy, detailing options for Scientific Advice/PIP/IMPD while coordinating the preparation of briefing packages and agency meeting preparations.
- Prepare strategic recommendations for global regulatory and development teams to align global product strategy with Area regulatory and commercial objectives.
- Define and implement the Area filing strategy, identifying risks and suggesting mitigation strategies.
- Lead, plan, and execute regulatory activities that support lifecycle maintenance within the Area, proactively identifying compliance risks and remediation needs.
- Act as the GRPT & ARPT representative, ensuring the regulatory interests of the Area and Affiliate are well-represented at GRPT meetings.
- Facilitate the review of CMC, QRD, PSUR, and labeling submissions and the approval of product-related packaging to ensure regulatory compliance.
- Engage with EMA or Area Health Authority(s) on behalf of the Product Lead when necessary.
- Ensure meticulous planning and tracking of activities, particularly submissions and key correspondence, utilizing internal tools effectively.

