My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Regional Strategist on an initial 12 Month...
My Client a Global Pharmaceutical Company has opened a new vacancy and is looking to recruit a Regulatory Strategist - CMC on an initial 12 Month contract to be based at either their offices in Surrey or Kent.
Accountable for CMC site transfer and other site related change submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets.
- 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.
- Maintain systems and databases per internal SOPs and policies.
- Work in collaboration across the regulatory organization with stakeholders (such as the global regulatory lead and the Company Country Office) to deliver efficiencies in Regulatory submissions and processes.
- Manage CMC post approval manufacturing site transfer submissions for the EuCANZ Region (EU, EME and ANZ)
- Manage post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL/GRS-CMC, PCO, Labelling team, Submissions Management) to ensure a CMC 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 and 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 GRA 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.
- Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
Education & Skills:
- Bachelor's degree or equivalent in Life Sciences.
- Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
- Strong knowledge / background of EU (EU and non-EU) regulatory procedures and requirements 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@SRG.co.uk or +441753 589673