Regulatory Affairs Consultant
To strengthen their team, Business & Decision Life Sciences is looking for RA experts to oversee the development, coordination, follow-up and strategic and operational management of regulatory activities associated with the development and life cycle of prophylactic or therapeutic drugs, at both national and international levels.
This position requires collaborating and interacting with the different departments within the client (Preclinical, Production, Quality Assurance, Clinical and Management).
- Liaise between the GRA organisation and Manufacturing Performance Unit on regulatory compliance matters including deviations and change controls.
- Follow-up of MA (marketing authorisation) and of regulatory life-cycle activities on client’s products in Europe and Worldwide.
- Writing, review and approval of all source documentation supporting CMC variations
- Update of internal tracking system linked to their RA activities
- Be the Single Point of Contact (SPOC) for any topic related to regulatory affairs.
- Identify key issues on resource or registration activities
- Contribute to preparation and review of PQR (Product Quality Review)
- Coordinate the requests for market specific requirements
Therefore, it is mandatory that the candidate clearly understands the pharmaceutical business and possesses strong RA knowledge.
- Scientific/Engineering degree
- Fluent spoken and written English and French
- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
- Knowledge of regulatory procedures / systems / guidances eg. Opal, CTD section (Module 1, module 2, module 3, module 4 and module 5)
- Experience in cGMP research laboratory or in regulatory/drug development/public health organization
SOFT SKILLS :
- Manages own time to meet agreed short-term targets
- Ensures the coherence between contributions / quality of final results
- Be able to lead and manage cross-functional projects in a multidisciplinary environment
- Excellent communication and negotiation skills
- Autonomous and results-driven
- Ability to work under pressure due to the requested flexibility and reactivity of the activities