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Regulatory Affairs Consultant

Business & Decision

Reference : BUMG00650

Position and missions

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.

Profile

HARD SKILLS:

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

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