Regulatory Strategist
Antwerp
Life Sciences - Regulatory Affairs
Master
Work experience: 3-5
Reference number: 92269

Join a forward-thinking and dynamic team committed to excellence in the pharmaceutical industry. This position offers an exciting opportunity to contribute to impactful projects that enhance patient care globally.

We are seeking a driven and knowledgeable Regulatory Strategist who thrives on navigating complex regulatory landscapes and ensuring compliance for innovative products. As an ideal candidate, you possess a solid understanding of product registration processes and enjoy collaborating with diverse teams to achieve strategic objectives.

  • You take full ownership of one or more products throughout their lifecycle.
  • You engage in new product introductions and manage existing products consistently.
  • You assume strategic regulatory responsibilities to guide products through the regulatory process.
  • You support regulatory submissions, including CTD, BLA, NDA, and ensure compliance across the Pfizer portfolio.
  • You collaborate with cross-functional teams to deliver high-quality CMC submissions.
  • You communicate with regulatory colleagues to address and resolve potential issues.
  • You manage timely responses to Board of Health requests and assess post-approval changes.

Additionally, we are looking for a resourceful Technician to support our execution-focused activities through standardized tasks. The ideal candidate is a self-motivated individual eager to contribute to team success in a collaborative environment.

  • You execute standardized tasks, such as requesting documentation and preparing forms.
  • You participate fully in team meetings and integrate yourself within the group.
  • You support the team with limited ownership on regulatory activities.

What are we looking for?

  • You possess a Master’s degree in Pharmacy, (Bio)medical sciences, or a similar field.
  • You have a minimum of 3 years of experience in the pharmaceutical sector, particularly in regulatory affairs, or equivalent experience through a PhD.
  • You have strong knowledge of CMC and/or Regulatory Affairs.
  • You demonstrate excellent analytical and communication skills.
  • You are capable of working independently while being a team player.
  • You adapt well to a dynamic environment and possess a strong willingness to learn.
  • You are fluent in English in both written and spoken forms.

What do we offer?

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.

Luckas Dom
Business & Talent Consultant Life Sciences, Food and Biotech
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