Associate Director Regulatory Affairs

Job Title: Associate Director / Director, Global Regulatory Affairs

Location: Germany (office around once a month)

Employment Type: Full time, permanent

We're partnering with a leading global pharmaceutical company to appoint an experienced Associate Director / Director, Global Regulatory Affairs .

This is a high-profile strategic role supporting global development programmes, with a strong focus on Europe. You'll play a key role in shaping regulatory strategy, leading interactions with regulatory authorities, and partnering with cross-functional teams to support innovative products through development and registration.

What you'll be doing:

• Develop and execute global regulatory strategies across development-stage and marketed products
• Act as a key regulatory advisor on European regulatory activities and health authority interactions
• Lead regulatory planning for major development milestones and submissions
• Provide strategic input across MAA, CTA, IND, NDA, Variations, Scientific Advice, PIPs and related regulatory activities
• Drive responses to health authority questions and support regulatory risk management
• Partner closely with Clinical, Medical, CMC, Safety, Labelling and Commercial teams globally
• Support product lifecycle activities and market expansion initiatives

What we're looking for:

• 7-12 years' experience within Regulatory Affairs in pharma or biotech
• Experience developing and driving regulatory strategy within global development programmes
• Experience with key regulatory submissions and agency interactions
• Strong understanding of drug development and global regulatory requirements
• Good working knowledge of CMC-related regulatory considerations
• Ability to influence stakeholders and operate effectively within global matrix organisations
• Degree in Pharmacy, Life Sciences, Medicine, Chemistry or a related scientific discipline

Nice to have:

• Experience within Oncology, CNS, Cardio-Renal, Immunology, Nephrology or other specialty therapeutic areas
• Exposure to biologics or complex products
• Previous leadership or people management experience

Why consider this opportunity?

• Strategic global role with significant European exposure
• Opportunity to work directly with senior global stakeholders
• Strong visibility across international development programmes
• Excellent opportunity to influence regulatory strategy and business-critical decisions

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