An internationally renowned pharmaceutical organisation is seeking to hire a CMC Regulatory Strategist for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
The CMC Regulatory Strategist will be 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. This includes HA query management. They will ensure transparency and excellence in the evaluation, definition, and execution of regulatory strategies, as well as confirming that dossiers are produced and dispatched to assigned markets according to their defined filing plan and are submission ready. Furthermore, the CMC Strategist will maintain systems and databases per internal SOPs and policies.
Job Responsibilities:
- Managing CMC post approval manufacturing site transfer submissions for the EuCANZ Region (EU, EME and ANZ).
- Managing 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.
- Communicating changes to regulatory requirements and updating the appropriate system in a timely manner.
- Supporting planning and monitoring activities, updating timelines when necessary, and communicating changes to the relevant partners.
- Authoring local submission components as needed.
- Ensuring submission packages are reviewed against local CMC requirements for consistency and completeness
- Liaising with the manufacturing sites for obtaining supporting documents as needed.
- Ensuring thorough understanding and application of GRA procedures.
- Contributing to local and regional regulatory initiatives, promoting a culture aligned with company values and which supports compliance, innovation, and talent development and retention.
- Ensuring internal regulatory processes and procedures are well documented
- Identifying and supporting efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.
- Understanding local regulations and trends for assigned markets.
Skills and Requirements:
- Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science subject. MSc, MBA, or PhD may be an advantage
- 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
- 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.
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
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 contact Keri Marshall at +44 203 871 8093 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.
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