Regulatory Affairs Manager

We are seeking a highly skilled
Regulatory CMC Manager
to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This is a unique opportunity to contribute to global submission plans, refine regulatory strategies, and drive continuous improvement within a dynamic and forward-thinking environment.

what we offer

• hybrid model of work
  for flexibility and convenience,
• company car
  to support your mobility needs,
• comprehensive
  private medical care
  and
  life insurance
  for you and your family,
• a robust
  company pension plan
  to secure your future,
• reimbursement for sports activities
  and access to
  well-being programs
  to promote a healthy lifestyle,
• annual bonus
  recognizing your contributions and achievements,
• beneficial leave policies
  to support your personal and professional needs.

your tasks

• participates as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
• actively participates on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.
• develop and execute global CMC regulatory strategy.
• leads the preparation of regulatory dossiers for submission to Health Authorities.
• develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.
• may participate in selected initiatives within CMC RA / GRA.
• participates in and conducts due diligence/licensing evaluations as needed.
• drives a culture of continuous improvement and communicates critical issues.
• ensures the CMC development and commercial product regulatory strategy meets global regulatory requirements.
• assures connectivity to the overall global regulatory strategy through partnership and communication with other departments.
• refines regulatory strategies as new data become available.
• develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.
• effectively and tactfully communicates with health authorities; maintain good rapport and credibility.
• reviews CMC regulatory dossiers for global submissions throughout the product lifecycle.
• provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.

what we expect

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent.
• proficiency in English (min. C1).
• demonstrated ability to communicate regulatory requirements.
• solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.
• strong attention to detail with high-level verbal and written communication skills
• communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
• demonstrates model behavior that understands what the priorities are and encourages others to drive for results
• experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
• good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
• some understanding of competitors in the area and what they are doing in early/late development

Employment agency entry number 47

this job offer is intended for people over 18 years of age