Europe Regulatory Affairs Manager

Implement regulatory strategies & deliverables for a portfolio of products in early‑development, late‑development or marketed status for the Europe‑Area Regulatory Affairs (ERA), covering EU and non‑EU countries such as CEE, Israel, Turkey, Switzerland and the UK. Ensure fair representation of EU interests in global regulatory product teams while aligning with the overarching global regulatory strategy and regional requirements.

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• Implement regulatory strategies and deliverables, including effective planning, tracking, and archiving of activities, especially submissions for early/late development and marketed products.
  
• Co‑ordinate review of CMC, QRD, PSUR, labelling submissions and product‑related packaging approvals to ensure regulatory compliance.
  
• Support the drug development strategy: defining options for Scientific Advice/PIP/IMPD, creating briefing packages, and coordinating and leading agency meetings logistics.
  
• Act as the primary RA interface with the Commercial Area Brand Team and represent RA on Area Brand Teams.
  
• Provide strategic input for registration, ensuring business needs are met by anticipating and mitigating regulatory risks.
  
• Interface with RA personnel in affiliates, providing product updates in Area Regulatory Product Teams (ARPTs) and local health authorities where appropriate.
  
• Represent ERA in EMA interactions for relevant products.
  
• Lead and support RA personnel across affiliates through ongoing communication; assess specialist data for registration against ERA requirements, identify gaps, and develop mitigation strategies.
  
• Contribute local regulatory implications through participation in teams and working groups (e.g., submission, labelling negotiations).
  
• Ensure regulatory compliance within ERA for assigned compounds/products, implementing remediation plans as required.
  
• Support development and implementation of new processes that meet regional regulations and business needs.
  
• Maintain accurate registration activity notifications and database entries for allocated projects.
  

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• Graduate in pharmacy, biology, chemistry, pharmacology or a related life‑sciences subject, or equivalent experience.
  
• Sound knowledge of pharmaceutical regulations, guidelines, and national regulations within the assigned region.
  
• Relevant experience in pharmaceutical Regulatory Affairs.
  
• Experience with regulatory procedures (including CP/DCP/MRP) and contribution to the effective functioning of the ERA team.
  

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• Demonstrated planning and organisational skills.
  
• Ability to prioritise and manage multiple projects.
  
• Collaboration across the organisation.
  
• Understanding of business needs and impact of regulatory issues.
  
• Strong interpersonal and negotiation skills and influence without formal authority.
  
• Excellent written and verbal communication skills in English.
  
• Experience working effectively across cultures and in a complex matrixed environment.
  
• Sensitivity to ERA culture and ways of doing business.
  
• Willingness to travel (minimum 5 %).
  
• Computer literacy.
  

AbbVie is an equal‑opportunity employer committed to integrity, innovation, and community service. Equal Opportunity Employer / Veterans / Disabled.

Full‑time

Regulatory Manager • Maidenhead, England, UK