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: 

RA-lifecycle management  

• Regulatory activities associated with life cycle management activities in the US, the EU and globally – including  
  • Regulatory advice to the product/project teams 
  • Develop timelines for lifecycle management activities and ensure execution  
  • Develop and/or review regulatory documents, including product labelling, in cooperation with subject matter experts  
  • Contact to regulatory authorities
• Contribution to regulatory strategies for the MC2 product portfolio 
• Submission management of activities related to lifecycle management 

RA–CMC 

• Provide CMC regulatory advice to the project teams on global development programs 
• Develop timelines for CMC parts of the dossier and follow up with subject matter experts 
• Develop and/or review regulatory CMC documents  
• Review and provide regulatory assessment to proposed CMC changes (Change Control system) 
• Preparation of responses to CMC questions from Regulatory Authorities 
• Participate in submission management of CMC part  

Pharmacovigiliance 

• Management of safety reporting through external pharmacovigilance vendor (clinical phase/post-marketing) 

General 

• Archiving of regulatory documents 
• Support regulatory management system 
• Support QMS from a regulatory perspective 
• Maintain knowledge of current global rules, regulations, and guidance governing development of drugs in all phases of development – and during maintenance 

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.