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Exciting opportunity as Regulatory Affairs Manager (RA Manager) within topical drug products.
As MC2 Therapeutics is expanding, they are looking for experienced RA Manager(s) for newly established position(s) to take responsibility for regulatory activities related to life cycle management, regulatory CMC, and pharmacovigilance. It is a requirement for the successful applicant to have significant knowledge and experience in a subset of the following areas, but not necessarily all of them.
With direct report to the COO and in cooperation with VP RA.
Your main responsibilities will, depending on candidate profile, include:
Your qualifications are 5-10 years of experience from the pharmaceutical or biotech industry, including regulatory activities and pharmacovigiliance related to drug products. Ideally, but not necessarily you have regulatory experience with the field of cosmetics and biocides (hand sanitizer) in addition to drugs. You have a good knowledge of European and US pharmaceutical legislation, relevant guidelines, procedures and requirements. Finally, you have strong regulatory writing skills, and excellent problem solving, communication and strategic planning skills.
You have a Master’s Degree in Pharmaceuticals or the like.
You are a person who is very structured in your working methods with attention to details, and you have a systematic/organized approach that sets high quality standards. You are a team-player, able to positively influence team members at all levels with a “can do” attitude. You are proactive, a quick learner and an independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion. You are also open-minded and have a good sense of humour, while when necessary you must be robust and able to both listen to and stand firm on valid arguments.
Travelling: Approx. 5-15 days per year. [Linjeskift til tekstombrydning]
Domicile: Hørsholm, North of Copenhagen.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Anne Thomsen, Unique Human Capital on M: +45 31 40 01 11. All applications must be in English and are treated confidentially.