Regulatory Affairs Manager

We're looking for a Regulatory Affairs Manager to play a key role in supporting the development, registration, and life cycle management of innovative vaccine candidates across Europe. You'll manage submissions, ensure compliance, and collaborate globally to bring life-changing vaccines to patients.

*This is a 5 month-contract position.

What You'll Do

• Support regulatory activities related to the development, registration, and life cycle management of vaccine candidates in Europe.
• Manage assigned regulatory projects, including dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region.
• Ensure all necessary applications are filed and maintained in compliance with applicable regulations.
• Provide regulatory oversight for assigned clinical trials conducted in the region.
• Offer regulatory guidance on non-clinical and clinical aspects of drug development and approval, ensuring adherence to relevant regulations.
• Collaborate with global regulatory counterparts to ensure alignment and execution of the global regulatory strategy for assigned projects.
• Demonstrate a strong commitment to quality in all areas of responsibility.
• Lead and direct the work of others within a matrixed organization.

Core Responsibilities

• Work closely with regional regulatory leadership and local operating companies (LOCs) to ensure alignment and execution of regulatory strategies during file preparation, submission, review, approval, and life cycle management.
• Oversee the content, management, compilation, and timely availability of CTD Module 1 regulatory components for assigned regions/countries, ensuring filings meet local regulatory requirements and are right-first-time.
• Support preparation and management of local regulatory components and filings (e.g., MAA, variations) and contribute to local label development.
• Ensure compliance with internal processes and policies as well as regional regulatory requirements, maintaining accuracy and quality in all communications.
• Assist in preparing for health authority interactions and meetings within the region for specified projects.
• Manage submission components in the Electronic Document Management System (EDMS).
• Ensure proper filing and archiving of regulatory documentation and health authority communications in compliance with SOPs.
• Maintain comprehensive regulatory archives and chronology files for vaccine projects, including submission documents, contact reports, and correspondence.
• Track regulatory activities and commitments in applicable systems.
• Actively participate as a member of global regulatory teams supporting product activities.
• Plan and execute regulatory projects and initiatives as assigned.

What We're Looking For

• Bachelor's degree required; advanced degree preferred.
• Minimum of 6 years of pharmaceutical industry experience, including at least 3 years in regulatory affairs or a combination of regulatory and related experience in vaccines.
• Proven experience managing EMA filings via the Centralized Procedure, ideally resulting in first-time approval, or managing multiple programs in related development areas.
• Vaccines and/or biologics experience is essential.
• Experience with global regulatory filings is a plus.
• Ability to interpret scientific issues across projects as they relate to regulatory requirements and strategy.
• Strong skills in oral and written communication (English), timeline management, negotiation, integrity, and adaptability.
• Excellent collaboration skills with global, regional, and local teams, as well as cross-functional groups; proactive in identifying regulatory issues and offering creative solutions, including risk mitigation strategies.
• Exceptional organizational skills and attention to detail.
• Team-oriented mindset.