Compliance and Regulatory Specialist

il y a 6 jours


Bruxelles, Région de Bruxelles, Belgique Planet Pharma Temps plein

At Planet Pharma, we are passionate about delivering transformative therapies to global markets. As a highly skilled Regulatory Project Manager, you will play a critical role in driving our mission forward by planning, managing, and overseeing global regulatory submission activities across the product lifecycle.

The ideal candidate will bring expertise in global submission planning, cross-functional team leadership, experience with rare disease and biological development, and a strong background within the biotechnology or pharmaceutical industry. You will be responsible for developing and executing comprehensive global regulatory submission plans for investigational and marketing applications (e.g., IND, NDA, BLA, MAA) in collaboration with cross-functional teams.

Responsibilities:

  • Ensure compliance with international regulatory requirements.
  • Lead cross-functional project teams to deliver high-quality regulatory submissions.
  • Serve as the primary point of contact for health authorities and regulatory agencies.
  • Monitor and interpret global regulatory guidelines and trends.
  • Identify and mitigate project risks.

Qualifications and Experience:

  • Bachelor's degree in life sciences, pharmacy, or a related field (advanced degree preferred).
  • A minimum of X years of experience in regulatory project management within the biotechnology or pharmaceutical industry.
  • Proven track record of managing global regulatory submissions and working with health authorities in multiple regions.
  • Strong knowledge of regulatory requirements and submission formats (e.g., eCTD).
  • Excellent project management skills.
  • Exceptional interpersonal and communication skills.


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