Regulatory Affairs Specialist

hace 3 días

Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo
About Galderma

Galderma Pharma S.A. is a leading global dermatology company dedicated to advancing the science of dermatology. With a rich legacy in the field, we have established ourselves as a pure-play dermatology category leader, present in approximately 100 countries. Our innovative, science-based portfolio of premium brands and services spans the full spectrum of the fast-growing dermatology market, including Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.

Our Mission

We are committed to empowering individuals and patients through superior outcomes in partnership with healthcare professionals. Our mission is to advance dermatology for every skin story, and we believe that by reflecting the perspectives of our diverse customer base, we will deliver better outcomes.

Job Title: Regulatory Affairs CMC Specialist

We are seeking an experienced Regulatory Affairs CMC Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC (Chemistry, Manufacturing, and Control) dossier sections of assigned products.

Key Responsibilities:
  • Contribute to global regulatory CMC strategies
  • Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation
  • Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them
  • Write/assemble CMC sections of regulatory submissions
  • Develop and maintain project plans and schedules for CMC submissions
  • Ensure all CMC dossiers are stored in the company database
  • Provide guidance on ICH, FDA, and EU CMC guidelines
  • Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals
  • Share knowledge and experience with other team members
  • Collaborate with service providers contracted to support a project, if appropriate
Requirements:
  • Effective experience in CMC Regulatory Affairs
  • Background in pharmaceutical industry
  • Experience with topical and/or systemic drugs (Biologics and/or Small Molecules)
What We Offer:

We offer a competitive compensation package with a bonus structure and extended benefit package. You will have the opportunity to work in a hybrid work culture and participate in feedback loops, where a personalized career path will be established. You will be joining a growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.

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