Offer

• interim assignment of at least 6 months, with possibility of extension
• leading position within Regulatory Affairs for the growing product portfolio
• hybrid role focused on strategic dossier management and EU submissions
• work within a pragmatic, entrepreneurial organisation with short lines and social impact

Position

As Senior Regulatory Affairs Specialist, you play a key role in the expansion of the in-house product portfolio of a specialised pharmaceutical company. Regulatory Affairs is one of the core functions, directly tied to strategy and execution of new product launches both nationally and internationally. In this interim position, you are responsible for assessing and executing regulatory strategies for an active pipeline of registered products and additional potential leads. You evaluate these leads based on market opportunity, profitability and risk. Your input helps determine whether the company will proceed with further development. You oversee submission procedures (DCP, MRP, national), compile eCTD dossiers and monitor regulatory progress. While CMC activities are mostly managed externally by CDMOs, you act as the primary point of contact for regulatory-related topics. You know when to probe and how to assess the adequacy of a CDMO’s regulatory work. When needed, you initiate bioequivalence studies and provide input on product ideas, translating them into feasible regulatory trajectories. You also contribute to repositioning well-established use products: older medicines being brought back to market that require strategic regulatory assessment in line with today’s standards. You collaborate with departments such as Quality, Supply Chain and Pharmacovigilance, and act as a knowledgeable sparring partner for both internal and external stakeholders.

In short, your expertise helps this evolving organisation take the next step toward independently bringing medicinal products to market.

Profile

• substantial experience with EU registrations of generic medicines (DCP/MRP)
• proven ability to prepare and submit EU dossiers successfully
• able to independently define and substantiate regulatory strategy
• skilled in communicating with both internal departments and external parties (such as CDMOs)
• strong knowledge of CTD structure and bioequivalence studies
• experience with tech transfers and CMC coordination is a plus
• fluent in English; Dutch is a plus

Organisation

Our client is a fast-growing pharmaceutical organisation. Most products are manufactured externally, while regulatory control and strategic direction remain in-house. The company focuses on socially relevant solutions, values initiative, and offers ample room for ownership and accountability.

Regulatory Affairs is closely involved in both commercial and strategic decisions and plays a key role in achieving the company’s international ambitions.

Response

Interested? Please send your resume and availability, quoting reference number DT/25-216, to Bjorn Schouten via, info@derksenderks.nl.

For more information, feel free to call, text or WhatsApp Bjorn Schouten on +31 (0)6 51649161.

Our client has exclusively appointed Derks & Derks B.V. to handle this vacancy. We therefore kindly ask you to direct all responses and applications through us.

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