Associate Director Regulatory Affairs

Das ist der Job

This is a high-profile strategic role supporting global development programmes, with a strong focus on Europe.

Darum lohnt es sich

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 #RegulatoryAffairs #GlobalRegulatoryAffairs #EMA #PharmaJobs #BiotechJobs #DrugDevelopment #MAA #ClinicalDevelopment #LifeSciences #RegulatoryStrategy #PharmaceuticalIndustry #Hiring #GermanyJobs #BiotechCareers #PharmaCareers #AssociateDirector #Director 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 .