Senior Manager Regulatory Affairs

vor 2 Wochen

Berlin, Berlin, Deutschland Medella Life Vollzeit 40.000 € - 120.000 € pro Jahr

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.

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