Regulatory Affairs Contractor
A major pharmaceutical company is advertising a vacancy for a Regulatory Affairs Contractor to be based in their UK office. The organisation supplies analgesics to British pharmacy and grocery sectors and prides itself on its 35-year long history. This is an exciting opportunity to work with an established organisation and enhance a career in the regulatory field.
- Overseeing and performing the necessary activities in order to maintain the company's site licences.
- Communicating with internal and external stakeholders on the status and requirements of all Regulatory submissions, providing guidance on the documentation required in support of applications.
- Collating and reviewing documentation in support of the Company's Marketing Authorisations prior to submission, ensuring supporting documents are 'right first time', and managing priorities to meet business objectives.
- Coordinating with the Regulatory partners of customers to ensure Marketing Authorisation compliance.
- Managing life cycle/post-authorisation changes for UK relating to CMC, Clinical, Safety, and Product Information changes.
- Informing the Head of Quality of any problems that could impact on the approval or maintenance of licence requirements (site and product licences).
- Identifying and managing Regulatory projects, setting up project plans to ensure that regulatory approvals are delivered and can be implemented on time.
- Developing and maintaining a detailed plan of all known Regulatory activities for the company licenses.
- Processing all Marketing Authorisations and Variation applications in a timely manner and ensuring that all responses to regulatory questions are undertaken in line with the defined targets.
- Ensuring that all applicable Legislation is adhered to.
- Rectifying any Regulatory compliance issues where possible, informing the Head of Quality where this is not achievable.
- Collaborating with other departments within the company, including sales and manufacturing teams to understand customer requirements.
- Working to the standards of EU GxP at all times.
- Assisting with due diligence activities for potential in-licensing opportunities for brand and generic products and evaluating dossiers.
- Preparing and maintaining the core CTD dossier for product licences.
- Preparing, reviewing, and maintaining artwork components and patient information (SPC, PIL, cartons and labelling) and associated mock-ups.
- Preparing weekly reports on the status of Regulatory Affairs for communication to Senior Management.
- Assisting in the training of new Regulatory and Artwork personnel as appropriate.
- Amending, approving, and implementing changes to Standard Operating Procedures to ensure continued compliance with current Regulatory expectations.
- Assisting the Head of Quality in hosting Regulatory inspections and customer audits.
- Acting as a primary contact for routine Regulatory queries and liaising with internal and external customers.
- Ensuring documentation is completed, filed, maintained, archived, and disposed of in accordance with GMP, data integrity guidelines, and local procedures.
Skills and Requirements:
- 'A' level (or equivalent) in a scientific subject.
- Relevant degree in a Pharmaceutical or scientific discipline.
- Minimum of 2 years of experience in a Regulatory Affairs role in the Pharmaceutical industry, including new product acquisitions, licence submissions, and variations.
- Experience in the use of the MHRA Submissions Portal.
- Previous exposure to liaising with Regulatory Authorities (including the MHRA) in relation to licencing and inspections.
- Extensive knowledge of the MHRA licencing submissions process, including the categorisation of licence variations.
- Experience in writing/ reviewing technical reports.
- Experience in the design and approval of artwork and patient information.
- Fluent in written and spoken English.
- 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.
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 Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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