Senior Regulatory Affairs Specialist
Venaris Executive Search ApS
Holbæk, Denmark
Pharmacosmos
Senior Regulatory Affairs Specialist
About the job Senior Regulatory Affairs Specialist
Help deliver life-changing therapies to patients worldwide at Pharmacosmos by driving EU regulated dossiers and ensuring regulatory compliance.
Make a lasting regulatory impact in a fast-growing pharma company
As a result of Pharmacosmos newly acquired company they are looking for a Senior Regulatory Affairs Specialist to join their department of thirteen dedicated employees to strengthen their regulatory operations across markets, primarily within EU. Reporting to the Head of Regulatory Affairs, you will ensure that Pharmacosmos products meet all relevant pharmaceutical GxP regulations from market approval and post-market surveillance. In close collaboration with your team, you will be responsible for compiling and maintaining documents related to regulations as well as coordinating and submitting regulatory dossiers. Finally, you will work closely with departments such as QA/QC, R&D, PV, Clinical and Non-clinical teams, and Sales & Marketing to ensure alignment with regulatory objectives.
Regulatory life sciences specialist with EU regulatory experience
We expect you to hold an academic degree in Pharmacy, Cand. Scient, or a related field. You bring substantial experience from the life sciences industry, particularly EU/global regulatory affairs, with additional experience in QA/QC, API production, or similar areas. Moreover, you have a proven track record of driving regulatory affairs projects and working with CMC (Chemistry, Manufacturing and Controls) and the EMA (European Medicines Agency). You are fluent in both written and spoken English and Danish, and you possess strong communication skills for liaising with regulatory authorities and providing regulatory guidance to the organization.
Personally, you are proactive and highly organized, with a strong attention to detail, as precision in preparing regulatory submissions and maintaining documentation is critical. You know how to adapt to changes in a dynamic, innovative, and fast paced working environment, and you acknowledge the importance of working effectively in interdisciplinary and cross-functional teams.
Additionally, you can manage multiple regulatory submissions, and projects simultaneously.
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 by Venaris Executive Search (www.venaris.dk). For more information regarding 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 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
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