Regulatory Strategy Lead

Holbæk, Denmark

Pharmacosmos

Regulatory Strategy Lead

About the job Regulatory Strategy Lead
Join the rapidly expanding Pharmacosmos and be at the forefront of regulatory innovation, shaping strategies that drive the success of cutting-edge therapies in a growth-driven environment.
Lead the development and execution of regulatory strategies
As a result of the successful completion of Pharmacosmos acquisition of G1 Therapeutics, they are now looking for a Regulatory Strategy Lead, who will be responsible for leading and developing the regulatory strategies for the newly acquired product and other projects as relevant. Reporting to the Sr. Director of R&D Regulatory Strategy, you will be developing the regulatory strategies to ensure that the companys drug development projects are successfully developed and approved in various markets worldwide. You will author and lead the preparation of critical regulatory strategy documents, including briefing documents for regulatory authorities, Pediatric Investigation Plans (PIP), and Orphan Drug Designation (ODD) requests. As part of the R&D department, this role involves working closely with cross-functional teams, regulatory authorities, and other stakeholders to navigate the complex regulatory landscape. Additionally, you will act as the regulatory contact for assigned clinical trial teams, providing strategic guidance and ensuring that regulatory milestones are met.

Scientific, strategic, and regulatory specialist
We expect you to hold an academic scientific degree and a strong foundation in life sciences or a related scientific discipline. You possess proven experience in developing and executing regulatory strategies and authoring regulatory strategy documents, while active participation in clinical regulatory discussions is considered a strong advantage. Furthermore, you have experience with Clinical Trial Applications (CTAs) and supporting, participating in, or leading regulatory authority meetings. Finally, you demonstrate exceptional proficiency in both spoken and written English, along with strong communication skills essential for liaising with regulatory authorities and crafting strategic documents.

Personally, you are analytical with a strategic mindset and the ability to develop and implement innovative and forward-looking regulatory strategies that support drug development projects and long-term business goals. To become a success, it is important that you are open-minded and enjoy working in a dynamic environment with a broad range of tasks. Lastly, you have strong collaboration skills with the ability to work across multiple areas.

Unlock innovation and accelerate growth with Pharmacosmos
This is your chance to embark on an exciting journey with Pharmacosmos, as they continue to seize strategic opportunities, driven by a strong ambition to innovate new medicines to address unmet medical needs and help patients globally. The recruitment process is carried out byVenarisExecutive Search (www.venaris.dk).For more informationregarding the position,please reach out to Executive Search Consultant, Charlotte Rod, on+45 3140 0672. All requests will be handled confidentially.If this position is for you,do not hesitate to apply byuploadingyour CV-it isnot necessaryto 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