Regulatory Affairs Manager

Job description – Regulatory Affairs ManagerOmet Pharma is a Swiss-Nordic generics company founded in 2020 by a team of former Actavis professionals. With offices in Sweden, Switzerland, and Bulgaria, we are experiencing rapid growth and seeking a hands-on Regulatory Affairs Manager to join our RA function.Our Bulgarian office serves as the operational hub for Supply Chain Management, Regulatory Affairs, Pharmacovigilance, Business Development, Sales & Marketing, and Administration. While our commercial focus is on the Nordic markets, our core team is based in Sofia.We value simplicity, structure, and common sense over bureaucracy. Our culture encourages open dialogue, constructive feedback, and continuous learning, so people enjoy coming to work every day. Key responsibilitiesThis is a broad and dynamic role, where the manager will get a chance to be involved, and trained in all aspects of RA. Depending on the skills set, the manager will for some responsibilities be leading and for others supporting.Participate in end-to-end regulatory affairs at Omet PharmaEvaluate pipeline products and help developing regulatory filing strategiesPlan and manage new MAAs via DCP/MRP and national procedures for the Nordic marketsPrepare and execute post-approval activities (variations, renewals, MAH transfers etc.)Coordinate preparation and updates of product information texts and artworksCommunicate the RA aspects of company projects to internal teams; maintain metrics and databasesEssential qualificationsProficiency in Generics EU regulatory affairs (filing of new MAAs or/ and maintenance)Experience in working with eCTD software and RIMS systemsFluent in English, both oral and writtenInternational experienceMotivation to excel in a small office environmentPreferred qualificationsMAA filing experience in the Nordic regionExperience interacting with national competent authoritiesStrong project management and communication skillsLocation/ reportingThis is a full-time position based in our Sofia office.This position reports into the Head of RAHow to applyTo apply, please send your CV to jobs@ometpharma.com, before Friday 21 Nov. NB applications via LinkedIn will not be considered.If you're passionate about regulatory affairs and want to help shape a growing generics company, we would very much like to hear from you.