Are you recruiting?
Advertise now
Viatris
The Role & What You Will Be Doing
Obtain and maintain marketing authorisations for products in designated EU and non-EU territories (internal and 3rd Party / BD). Perform any other regulatory activities as required by company strategy.
Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Officer role will make an impact:
Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.
Ensure on-time submissions for all safety related changes for assigned projects.
Ensure databases and systems (including D2, GLAMS, MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information is available for all assigned products.
Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.
Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
Prepare regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions with support from Line Manager.
Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.
Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Bachelors Degree is the field of Science/Technology/Pharmacy
Experience in a Regulatory/Quality/R&D role
Strong demonstrable capabilities in the use of software applications.
Must possess organization skills, time management skills and attention to detail.
Must possess strong communication skills, critical thinking skills, interpersonal skills and interpretation skills.
Expert in managing work within a highly matrixed organization.
Bachelor's degree
