Sales
RA Specialist
Summary
The RA Specialist manages regulatory variations and lifecycle compliance for marketing authorisations, including CMC dossier preparation, strategy development and coordination with cross-functional teams and regulatory authorities.
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Opportunity summary
Country: Denmark. Join Orifarm as our new RA Specialist and play a key role in managing regulatory variations, contributing to CMC strategies, and acting as a trusted regulatory partner About the job This position is a parental cover, expected to run for approximately a year. You can be based in Odense or Søborg, Denmark, or in Warsaw, Poland.
As our RA Specialist you will be responsible for ensuring compliance with regulatory requirements during the lifecycle management of Orifarm’s marketing authorisations. The role involves developing and executing regulatory affairs strategies, preparation of regulatory variation packages as well as authoring the CMC part of the regulatory dossiers.
The position requires a deep understanding of the pharmaceutical manufacturing processes, analytical testing and pharmaceutical legislation and guidelines, coupled with strong communication skills.
As our RA Specialist you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales to ensure variations are managed in due time to ensure uninterrupted supply of our medicines to patients1 …
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