- More than 15 years’ experience in the pharmaceutical industry
- 7 years of CMC Regulatory consulting.
- More than 8 years in Research and Development.
- Preparation of Global regulatory strategies
- Manufacturing site rationalisation (site transfers)
- International CMC variations
- EU Post Marketing Applications (Type IA, IB, II) for Mutual Recognition, Decentralised, Centralised and National procedures
- Authoring Module 3 CTD, ACTD and International Registration Files
- CMC authoring experience with drug products and drug substances
- Ensuring compliance with current regulatory requirements and standards
- SPC, PIL and labelling review and updates including MHRA PIQU submissions
- Successful compilation and submission of Phase 2 Clinical Trial Application
- Gap analysis
- Compliance projects
- Review of CMC data e.g. stability reports
- Responding to regulatory authority questions
- Co-ordinating PI/pack updates with appropriate departments
- Training and mentoring regulatory colleagues
- Liaise with market affiliates to coordinate submissions and approvals
- Preparation of high quality, detailed regulatory documents using varied information sources.
- Preparation of Cosmetic Product Information File in compliance with EU regulation 1223/2009.
- Upload of Phase 1 clinical trial results to EudraCT
Seven years proven track record of providing excellent service to clients from remote offices through teleconferencing. You can be confident of the quality of work whether based on-site or remotely at the Bryanek Regulatory Cornwall office.