Senior Regulatory Manager - Emerging Markets
This is a new job opportunity at a biotech for a Senior Regulatory Manager to join their expanding team remotely. This is an exciting time to join this company who operate with Emerging across the United States, Europe and other international markets and have an extensive pipeline of products under development.
- Member of regulatory project team(s) representing the International Growth markets primarily for 1-3 marketed products.
- Responsible for driving development and implementation of International Growth Market (IGM) regulatory strategies for legacy registration submissions and lifecycle manaIGMent activities across four regions (LATAM, ASIA, CEE, MENA).
- Responsible for ensuring availability of contemporary regulatory documentation to support new submission and lifecycle management activities
- Provides regulatory support to IGM regional leads including submissions for NCE /NME.
- Responsibility for providing IGM strategic input for early development compound as member of regulatory project team (RPT)
Skills and Requirements
- BS degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject is required
- 3-4 years' experience in Regulatory Affairs in the pharmaceutical/biotechnology industry Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
- Good knowledge of applicable regulations, regulatory guidelines and submission requirements
- Ability to interpret regulations and guidelines
- Well organised with the ability to prioritise workload
- Ability to work independently with some supervision, handling a moderate to large volume of complex tasks
- Detail oriented with effective written and oral communication skills
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.