Regulatory Affairs Manager (Matternity Leave)
Localização Coimbra, Região de CoimbraFULL_TIME
Consultor Kyle Gonçalves
Data de publicação 5 de Setembro de 2022coimbra engineering-and-operations/operations 2022-09-14 2022-11-04 pharmaceuticals Coimbra Região de Coimbra PT Robert Walters https://www.robertwalters.pt https://www.robertwalters.pt/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
A multinational pharmaceutical company with modern facilities is currently recruiting a Regulatory Affairs Manager for their plant based in Lisbon.
About the position:
The RA Manager will manage the submission and approval of applications for new products and
international product variations, ensuring regulatory compliances, as well as the support of
regulatory activities in export markets.
Type of contract: 1-year contract, with great chance of renewal.
The RA Manager’s main responsibilities will be:
- Manage the submission and approval of applications for marketing authorizations in
- Manage the maintenance of MA’s for assigned products in Switzerland;
- Support applications for new MA variations and renewals in export markets (in close
collaboration with local team);
- Prepare/update and review internal regulatory SOP’s;
- Manage in the development of regulatory strategies for product acquisition (due diligence
activities), technical changes and maintenance for drug products;
- May support pharmacovigilance activities for Switzerland;
- At least 7 year experience of RA, a degree in Life Science (preferably PharmD, PhD or
- Experience in preparation and submission of new applications/variations in Europe,
Middle East and/or Switzerland;
- Experience working with both original and generic product documentation submissions.
- It is also mandatory an excellent English and Portuguese knowledge (French is a plus).
+351 926 635 673