Senior Regulatory Strategy Lead

Join Pharmacosmos and take a key strategic role at the intersection of regulatory strategy and business development, shaping the regulatory direction for pipeline expansion.

Drive regulatory strategy for new assets
As Senior Regulatory Strategy Lead, you will report directly to Head of Regulatory Affairs. You will be responsible for developing and executing global regulatory strategies that support both Pharmacosmos current portfolio and its future growth ambitions.

With a strong strategic lens, you will ensure regulatory considerations are embedded early in decision-making – supporting business development, M&A activities, and the identification and evaluation of new assets and external opportunities. You will lead the development of global regulatory pathways, assess regulatory feasibility and risks, and support investment decisions with clear regulatory insight. In addition, you will author and drive key regulatory strategy documents such as briefing documents for health authorities, Pediatric Investigation Plans (PIP), and Orphan Drug Designation (ODD) applications, as well as leading a cross-functional team toward obtaining regulatory milestones such as Marketing Authorization Applications (MAAs).

Acting as the regulatory contact for clinical development teams, you will provide guidance across clinical trial activities, submissions, and regulatory interactions, while continuously monitoring regulatory trends and translating regulatory intelligence into actionable recommendations. Finally, you will collaborate across key internal stakeholders spanning Business Development, R&D, Clinical and Non-clinical teams, Market Access & Commercial, and Quality Assurance, and contribute to governance forums and senior leadership decision-making.

Senior regulatory strategist with strong business understanding
We expect you to hold an academic scientific degree within life sciences or a related field and to bring a solid regulatory background from the pharmaceutical or biotech industry. You have hands-on experience supporting or participating in business development initiatives, such as assessment of new assets, in-licensing opportunities, or M&A projects. You bring a holistic understanding of drug development processes and the pharmaceutical value chain, and you are able to assess regulatory feasibility, risks, and value potential of new opportunities. Excellent English skills, both written and spoken, are essential.

Furthermore, you have extensive experience developing and executing regulatory strategies across the drug development lifecycle and have actively contributed to or led interactions with regulatory authorities. Experience with authoring regulatory strategy documents, leading or supporting regulatory authority meetings, and working with Clinical Trial Applications (CTAs) is required.

On a personal level, you are analytical, strategic, and commercially aware, with the ability to translate regulatory complexity into clear and actionable recommendations. You demonstrate strong personal impact and credibility and are comfortable presenting and influencing at senior management level. You thrive in a dynamic environment with broad scope and multiple stakeholders, and you collaborate effectively across functions while maintaining decisiveness and momentum.

Shape the future of Pharmacosmos
This is your chance to join a growth-driven organization and play a defining role in enabling strategic expansion through regulatory leadership, insight, and impact. The recruitment process is carried out by Venaris Executive Search (www.venaris.dk). For more information regarding the position, please reach out to Senior Executive Search Consultant, Lars Nordlund, on +45 3123 3018. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV - it is not necessary to include a cover letter.

Pharmacosmos
Founded in 1965, Pharmacosmos is a global healthcare pioneer in carbohydrate chemistry and a leader in the development of innovative treatments for blood diseases, including iron deficiency anemia and cryopreservation technology. On September 18th, 2024, Pharmacosmos announced the successful completion of their acquisition of G1 Therapeutics, a commercial-stage oncology company. The acquisition aligns perfectly with Pharmacosmos' strategy by leveraging their extensive expertise in blood diseases, positioning the company for its next phase of growth and strengthening its global commercial portfolio. Headquartered in Holbæk, Denmark, Pharmacosmos employs 650 dedicated employees, with products marketed in over 40 countries worldwide. Please also visit www.pharmacosmos.com