Associate Director Regulatory Affairs

Job Purpose / Summary

The Associate Director (RA) will lead regulatory strategy, submissions, and lifecycle maintenance for assigned products / projects in the European / German / Central Eastern Europe region. This role ensures compliance with regulatory requirements, supports product development from early phase through to post-marketing, and acts as the regulatory liaison with health authorities. The role will also contribute to defining regulatory policy, monitoring regulatory intelligence, and optimising regulatory processes across cross-functional teams.

Key Responsibilities

• Lead the development and execution of regulatory strategies for assigned development programs and marketed products (including life-cycle management, variations, renewals, post-approval commitments).
• Manage preparation, review, and submission of regulatory dossiers (e.g. CTAs, MAAs, variation, renewals) in Germany / EU, ensuring quality, timeliness, and compliance.
• Coordinate with global regulatory strategy teams to ensure alignment between global and regional regulatory strategy, including product labelling, CMC, safety, and other functions.
• Engage proactively with health authorities (e.g. EMA, national competent authorities such as BfArM, PEI etc.), prepare for and lead meetings / scientific advice / negotiations.
• Provide regulatory input / guidance to R&D, clinical, CMC, quality, manufacturing, and safety teams throughout the drug development lifecycle.
• Monitor changes in regulatory legislation, guidelines, agency expectations, and emerging regulatory trends; assess their impact on existing and future projects.
• Ensure regulatory risk identification and mitigation - internal reviews for potential issues, crafting strategies to address regulatory concerns.
• Oversee regulatory operations for assigned programs: manage timelines, budget, resource allocation, and ensure maintenance of regulatory documentation, regulatory databases, SOPs, submission trackers.
• Support cross functional teams to ensure launch readiness (e.g. labelling, packaging, promotional materials, compliance).
• Mentor / coach regulatory affairs staff; build capabilities in the regulatory organisation.
• Contribute to global / regional regulatory intelligence, benchmark practices, and help improve efficiency of regulatory processes.

Qualifications & Experience

• Education: Bachelor's degree in Life Sciences / Pharmacy / Chemistry / Biotechnology; Master's / PhD preferred or equivalent.
• Significant experience (typically 8-12 years) in Regulatory Affairs in the pharmaceutical industry, including both product development and regulatory submission / maintenance in the EU / Germany.
• Proven track record of leading Marketing Authorisation Applications (MAA), variations, renewals, post-approval commitments, CTAs etc.
• Strong experience interacting with European and national regulatory authorities; experience handling scientific advice and complex regulatory negotiations.
• Good understanding of CMC, non-clinical, clinical, pharmacovigilance and safety aspects
• Strong written and verbal communication skills in English; German fluency (spoken and written) is highly desirable
• Exceptional project management skills: able to plan, prioritise, drive multiple submission‐related deliverables and deadlines across cross-functional teams.
• Analytical thinking, risk assessment / mitigation, strategic mindset.
• Experience managing people or leading functions / teams, mentoring others.
• Familiarity with regulatory intelligence, guidelines (ICH, EMA, EU directives/regulations), good practices in submissions and regulatory operations.

Other Requirements

• Willingness to travel as needed (e.g. to meetings with authorities in Germany / Europe, conferences etc.).
• Ability to work in German regulatory / legal context; understanding of national procedures, local regulatory requirements, possibly pharmacovigilance / safety requirements under German law.
• Experience with electronic submission systems, regulatory information management systems, eCTD format, etc.
• Strong leadership capabilities; able to influence at senior levels and across departments.
• Excellent organisational, planning and time-management skills.
• Ability to work in a matrix environment, dealing with multiple stakeholders.
• High attention to detail balanced with ability to see the big picture.
• Proactive, solution-oriented, adaptable in changing regulatory / scientific environments.
• Integrity and ethical mindset.