This attractive Regulatory CMC Consultant job is a great opportunity to join one of the pharma industry's biggest and most prestigious organisations. The company has been working for over a 150 years across multiple therapy areas including cardiovascular, neurology and immunology. This CMC role is based at their site in Surrey.
- Serves as a biosimilars expert and regional regulatory lead in the Europe regional lifecycle and growth team guiding and supporting the timely registration and approval of biosimilar assets in the non-EU EM markets such as Turkey and Russia from regulatory strategy through to submission/approval.
- Provides input to global regulatory strategies, to ensure the provision of data and documentation required for registration of the biosimilar assets in Europe is acceptable for submission to BoH, particularly non-EU Europe markets, such as Turkey and Russia. Collaborates with the Global and Pan-Europe Biosimilars Product Regulatory leads and interfaces with the Europe Country Regulatory Leads to identify and agree non-EU EM regulatory strategies, documentation requirements, submission plans, and execution.
- Collaborates with the PEH Global Policy team to understand the regulatory landscape for Biosimilars in European EMs and to progress advocacy actions in line with the company's corporate position at a market level.
- Establish and identify submission requirements for registration of biosimilars in non-EU EM markets and provide input to team as needed.
- To develop and support non-EU EM market regulatory strategies providing input to the teams as part of the global strategy to support the registration of the biosimilar portfolio and lifecycle changes for particular markets, and analyzes risk vs. benefit in these strategies.
- Member of the global regulatory sub team contributing regulatory advice for non-EU EMs to global project teams to inform CMC development in R & D, and/or clinical activities and ensure the generation of a high quality data package to support product registrations in non-EU EMs.
- Partners with non-EU Europe country regulatory leads to understand local requirements and to engage with the BoH, as appropriate to agree regulatory submission strategies and to improve chance of regulatory success. To identify any regulatory risks/mitigations associated with particular markets and mitigations and provide input to the team.
- Support the preparation of non-EU Europe regulatory documentation and manage submission activities to meet business and agency milestones. Agrees submission data requirements and deliverable dates with global regulatory leads, country regulatory leads, and internal technical teams in line with market requirements.
- Maintains an awareness of EU/global/EM regulatory requirements, legislation and guidance documents relating to biosimilars and assess the impact to the business and internal development programs.
- Establish and maintain non-EU EM regulatory intelligence and submission requirements for biosimilars in the company system.
- Ensure regulatory plans are monitored, progress/issues communicated to the Global Regulatory Lead and any risks (from emerging technical data, changing internal objectives or external threats, change(s) in regulatory requirements) mitigated.
- Supports implementation of systems, processes and procedures relating to regulatory strategy productivity.
Education and Experience:
- A higher degree may be an advantage but is not essential.
- Degree in pharmacy, biology, chemistry, pharmacology or related subject preferred.
- Strong technical background in drug development science
- At least 5 years experience in regulatory affairs / CMC regulatory affairs with specific biologics registration experience and preferably spanning the entire lifecycle.
- Biosimilars experience would be an advantage but is not essential.
- Experience working directly with EM health authorities is desirable.
- Personal traits would include ability to learn rapidly and strive for excellence. Flexible, adaptable and able to thrive in a dynamic fast paced environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.