Senior Regulatory Affairs Manager (m/w/d) – Berlin Your Responsibilities: Regulatory Strategy Development: Lead the creation and implementation of regulatory strategies for pharmaceutical products, including small molecules, biologics, and combination products, ensuring compliance with EMA, FDA, and ICH guidelines. Submissions & Approvals: Prepare, review, and submit regulatory dossiers (e.g., CTAs, MAAs, INDs, NDAs ) to health authorities and ensure timely approvals. Lifecycle Management: Oversee regulatory compliance throughout the product lifecycle, including variations, renewals, and post-approval commitments. Cross-Functional Collaboration: Partner with R&D, Clinical Affairs, Quality, and Marketing teams to integrate regulatory requirements into development and commercialization plans. Regulatory Intelligence: Monitor and interpret changes in regulatory frameworks, provide guidance to internal teams, and maintain proactive compliance. Health Authority Interaction: Act as the primary point of contact for regulatory authorities, addressing questions, inspections, and audits. Team Leadership: Mentor and develop junior regulatory affairs staff, fostering a culture of regulatory excellence. Audit & Inspection Support: Lead and support internal and external audits, ensuring readiness for inspections by EMA, FDA, and local authorities. Your Profile: Degree in Pharmacy, Life Sciences, Chemistry, or related field ; advanced regulatory certifications (e.g., RAC) are a plus. Minimum 5–7 years’ experience in pharmaceutical regulatory affairs, including dossier preparation and submission to EMA and/or FDA. Deep understanding of ICH guidelines, GMP, GxP, and pharmacovigilance requirements. Experience in cross-functional project management within drug development. Excellent written and verbal communication skills in German and English. Strong analytical thinking, decision-making, and leadership skills.