Head of Corporate Regulatory Affairs & CMC (RAC)
Ready to make a real impact in regulatory affairs?
We're looking for a dynamic Regulatory Affairs Expert (CMC & Compliance) to join our high-performing team. In this role, you'll help define global standards, support innovative development projects, and drive regulatory excellence across our sites. If you're passionate about pharma or biotech, thrive in a fast-moving environment, and want to grow your career while making a difference - we'd love to meet you!
Your Impact:
Shape and roll out regulatory standards across all global sites, driving compliance and excellence.
Ensure seamless regulatory maintenance for our products, always keeping customer needs and corporate requirements in focus.
Partner with local RAC teams and internal/external stakeholders to design smart CMC and regulatory strategies for new development projects - making sure corporate best practices are always applied.
Lead and support regulatory submissions (DMFs, CMC sections for INDs, IMPDs, NDAs, MAAs, and more), ensuring precision and efficiency throughout the process.
Act as a hands-on expert to embed and uphold corporate regulatory standards at operational sites.
Coordinate cross-functional regulatory activities during CMC development phases and advise customer project teams as needed.
Head up the corporate RAC team within the Corporate Quality Organization, championing consistency and high standards.
Own and continually refine the RAC processes within the Corporate Management Handbook, ensuring harmonization across the organization.
Maintain and optimize our e-CTD submission systems to streamline regulatory workflows.
What You Bring:
Ph.D. in Chemistry, Pharmacy, or equivalent scientific field.
Deep expertise in Regulatory Affairs for drug substances and/or drug products, especially around CMC development.
Solid foundation in GMP compliance.
Hands-on experience with e-CTD submission tools.
5+ years of experience working in Regulatory Affairs within pharma/biotech (drug substances or products).
5+ years in a regulatory, GMP, or consultancy leadership role.
Strong background managing interactions with regulatory authorities and clients.
Excellent intercultural communication skills and fluency in English (written and spoken).
A collaborative leadership style, with strong decision-making skills and a service-first mentality.
Flexibility and resilience - ready to step up when business needs demand.
Why Join Us:
Work in a high-energy environment with top-tier facilities and a supportive team culture.
Advance your career with structured professional development opportunities.
Enjoy flexible working hours with a 40-hour workweek.
Get a minimum of five weeks of vacation annually.
Benefit from childcare support and private travel insurance.
Receive comprehensive private accident insurance.
13th-month salary paid out without deductions, plus eligibility for profit-sharing in successful years.