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Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

BUSINESS SOLUTIONS by TakeTalentColmenar Viejo, Madrid, SPAIN
Hace 18 días
Descripción del trabajo

Taketalent is partnering with PharmaMar , a leading biopharmaceutical company dedicated to the research, development, and production of innovative oncology therapies , to find a Regulatory Affairs Project Manager with an international scope .

This is a hybrid position , ideal for professionals eager to manage strategic regulatory projects globally and contribute to the success of end-to-end innovative products.

The selected candidate will play a key role in managing regulatory submissions, global regulatory strategies, and cross-functional coordination , ensuring that projects meet the highest scientific and regulatory standards. This position has significant impact on the company and the international trajectory of PharmaMar's oncology R&D programs .

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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    Project Manager • Colmenar Viejo, Madrid, SPAIN