Regulatory Affairs Expert
We are seeking a seasoned Regulatory Affairs professional to join our Corporate Quality Organization. As a key member of the team, you will be responsible for shaping and rolling out regulatory standards across all global sites, driving compliance and excellence.
* Develop and implement regulatory strategies to ensure seamless product maintenance.
* Partner with local RAC teams and stakeholders to design effective CMC and regulatory plans.
* Lead regulatory submissions (DMFs, CMC sections for INDs, IMPDs, NDAs, MAAs) ensuring precision and efficiency.
* Embed and uphold corporate regulatory standards at operational sites.
* Coordinate cross-functional regulatory activities during CMC development phases.
Key Qualifications:
* 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.
* 5+ years in a regulatory, GMP, or consultancy leadership role.
Why This Role?
* 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.