Our client, a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Strategist (CMC) on an initial 6 Month contract. Role will be remote working to begin with, moving to their offices in Surrey.
To be 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 Upjohn products in Developed Market
- 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
- 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
Education & Skills:
- Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
- 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.
- Strong knowledge / background of EU regulatory procedures and requirements
- Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
- Regulatory experience including knowledge of Europe submission product lifecycle management processes.
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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