TakeTalent, in partnership with PharmaMar, is seeking a Regulatory Affairs Project Manager with international scope to lead strategic regulatory projects globally.
The role is hybrid, ideal for professionals eager to manage end‑to‑end regulatory submissions and contribute to innovative oncology therapies.
Key Responsibilities
* Develop and maintain international regulatory submission plans (MAA/NDAs, CTAs, INDs, variations, Orphan Drug Applications, Pediatric Investigational Plans, Scientific Advice Requests, etc.).
* Coordinate regulatory activities with internal departments: Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Manufacturing & Supply, Legal, Business Development, and Commercial.
* Contribute to defining global regulatory strategies, identifying risks and opportunities.
* Lead complex regulatory applications, including interactions with international authorities and external experts .
* Review clinical and scientific documentation to ensure regulatory compliance.
* Manage regulatory databases and collaborate on international regulatory strategies .
* Supervise CROs and work effectively with global project teams .
Requirements
* Degree in Health Sciences (PhD, MSc, or MBA preferred).
* Fluent in English, both written and spoken.
* Industry experience: at least 3 years in Regulatory Affairs and Project Management within the biopharmaceutical sector.
* Management of regulatory deliverables at the project level.
* Thorough knowledge of the drug development process.
* Knowledge of Business and processes in the pharmaceutical industry.
* Knowledge of clinical development, ideally oncology.
* Experience with electronic submission techniques – working on e‑CTD.
* Highly valued: Global knowledge in CMC, preclinical, and clinical development.
* International regulatory experience is an advantage, including interactions with authorities across multiple markets.
What We Offer
* Competitive salary + performance‑based bonus.
* Benefits package (private health insurance, stock plan, continuous training, company cafeteria, etc.).
* Flexible working hours with short Fridays.
* Opportunity to contribute to a leading oncology company with global impact .
* Commitment to diversity, equal opportunities, and an inclusive work environment.
If you meet the requirements and are looking for a professional challenge in regulatory affairs with international scope, we would be delighted to receive your application.
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