Our client, a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory CMC Strategist on an initial 6 month contract to be based at their offices in Surrey - when the offices reopen.
Accountable for supporting initial and post approval submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets. This includes HA query management, Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies, ensure dossiers are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready.
- Manage initial and post approval submissions for company 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 company RA procedures
- Contribute to local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention.
- 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.
- Understand local regulations and trends for assigned markets
- Work in collaboration across the regulatory organization with stakeholders (such as the global regulatory lead (GRL) and the country regulatory lead (CRL) to deliver efficiencies in Regulatory submissions and processes.
- Maintain systems and databases per internal SOPs and policies
Education & Skills:
- Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation.
- Knowledge of drug development practice, rules, regulations and guidelines.
- Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
- Prior experience in the pharmaceutical or related industry in Regulatory Affairs
- 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.
- Demonstrated experience of effective delivery in a matrix environment.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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