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 role will be based in Surrey, UK on a contract basis.
- 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.
- Maintain systems and databases per internal SOPs and policies.
- 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
- Manage initial submissions and post approval manufacturing site transfer submissions for the Europe Region
- 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 PEH RA procedures
- Contribute to local and regional regulatory initiatives promoting a culture aligned with the 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
- Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
- 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 regulatory procedures and requirements
- Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
- Candidates must have worked on a site transfer project
- 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.
- 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.
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.