Senior Manager, Affiliate Regulatory Affairs
Proclinical are recruiting a highly motivated Senior Manager, Regulatory Affairs, to manage the European regulatory activities of products in late stage development through to gaining marketing approvals and post-approval. This Regulatory affiliate role will involve contributing to the development of regulatory strategy for specific projects, including providing support to the set-up of compassionate use programs, review of commercial / medical materials and support for all European launch activities. The individual will also work closely with supply chain and quality assurance to ensure country-specific regulatory compliance.
- Provide country-specific strategic European regulatory leadership to European Country General Managers to support successful product launches
- Work closely with supply chain and quality assurance to identify country-specific regulatory requirements and potential risks, as well as provide support as needed for obtaining GMP / GDP licenses, as relevant
- Lead the regulatory review of commercial / medical materials working in partnership with internal groups and external Regulatory partners if necessary
- Lead the regulatory review of artworks in partnership with Supply Chain and external Regulatory partners if necessary
- Lead the regulatory review of educational materials if applicable, as the submission and negotiations with the local European Regulatory Agencies
- Lead negotiations with local European Regulatory Agencies, as applicable
- Manage relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met
- Contribute to the preparation of new regulatory guidance and communicate the impact of new regulatory requirements across the organisation
- Maintain dashboard of country-specific activities, including label management and other regulatory activities
- Provide input into the implementation of a Regulatory Information Management system (RIM), to ensure effective tracking of country-level regulatory activities including label changes, and support business readiness for EU implementation of IDMP
Skills and Requirements
- University Degree in Science or related discipline. A higher degree would be desirable.
- Ideally a combined mix of large company best practices and smaller company adaptability and experience
- Sound knowledge and experience of European Regulatory Affairs and associated requirements, with if possible, experience of country-specific European Regulatory requirements for innovative products in late-stage development and post-approval
- Experience in interfacing with Regulatory Authorities in Europe and an excellent track record of building relationships with and influencing Regulatory Agencies
- Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
- Has strong blend of being a team player, but also able to work on own initiative and prepared to take ownership and responsibility for his/her actions
- Communication skills to interact with all expertise aera (commercial, medical, supply chain, quality, other regulatory functions)
- German native speaker or enough level of German to interact with local Regulatory Agencies and fluent English verbal and written communication skills
- Results focused and able to work under pressure and meet deadlines
- Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.