Regulatory Affairs Manager
A large biopharmaceutical company are looking for a talented Regulatory Affairs Manager to join their team working from home. This organisation is known for their extensive experience in discovering, developing human therapeutics.
- Ensuring the regional needs are well implemented in collaboration with relevant regional stakeholders
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Skills and Requirements
- Regulatory knowledge in regional legislation Working with policies, procedures and SOPs
- Regulatory Affairs CMC Project Management of a large global commercial product project (including biologics, small molecules and device considerations).
- Ideally experience with coordinating and tracking global Regulatory Affairs CMC projects, plus regulatory aspects of national requirements, change control management, and working with cross-functional internal and external stakeholders
- Experience in Regulatory project management and regulatory writing.
- Good communication skills and experience working cross-functionally and globally.
- Experience of emerging markets Russia/Balkans
- Interaction with multiply stakeholders, Reg affairs operations
- Clinical (CTA) experience is less important, candidates must have POST APPROVAL experience
- Ideally will come from a big pharma/biologic experience
- Personal that can work independently
- Ideally 5 + years in a similar level role
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
A full job description is available on request.