Regional CMC Consultant
An exciting opportunity has arisen for a Regional CMC Consultant to join a large pharmaceutical company. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry. The company has been established for more than 150 years and is a major supplier to the NHS.
- Manage initial and post approval submissions for Upjohn products in Developed Markets
- Manage initial and post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL, CRL, Labelling team, Submissions Management) to ensure a submission ready dossier.
- Communicate changes to regulatory requirements and update the appropriate system in a timely manner
- Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners
- Author local submission components as needed
- Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
- Liaise with the manufacturing sites for obtaining supporting documents as needed
- Ensure thorough understanding and application of Upjohn RA procedures
- Assist in ensuring internal regulatory processes and procedures are well documented
- Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
Skills and Requirements
- Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
- MSc, MBA or PhD may be an advantage
- Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
- Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
- Demonstrated regulatory experience with a pharmaceutical company with proven examples of contribution.
- Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
- Regulatory experience including knowledge of Europe submission product lifecycle management processes.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.