RA Compliance Expert Transition Team
ProClinical is currently recruiting for an RA Compliance Expert Transition Team position at a global pharmaceutical company across various therapeutic areas. This top 10 company is looking for someone to join their team in Belgium.
The RA Compliance Expert will manage regulatory activities for the company's Vaccines Division and interact with external collaborators. The Health Authorities have a direct impact on the release of the lots on the markets and then on the capacity of the Belgian plant to deliver to its clients; it is therefore very important that the candidate clearly understands the pharmaceutical business, Regulatory Affairs, and comes from a technical background.
- Liaising between the GRA organisation and Manufacturing Performance Unit on regulatory compliance matters, including deviations and change controls.
- Acting as the Single Point of Contact (SPOC) for any topic related to regulatory affairs.
- Following up of Marketing Authorisation (MA) and of regulatory life-cycle activities on various vaccines wherever the company is still Marketing Authorisation Holder (MAH); ensuring that these licenses are maintained in compliance with regulatory requirements worldwide.
- Reviewing and approving of all source documentation supporting CMC variations impacting the company's vaccines.
- Maintaining close contacts with the Local Operating Companies in the countries where the company is still MAH.
- Identifying key issues on resource or registration activities that could prevent achieving objectives or that could lead to supply issues and pro-actively propose solutions to manage to solve the problem.
- Coordinating questions & answers and commitments to external partner and to Boards of Health (BOH).
- Preparing and reviewing Product Quality Review (PQR).
- Coordinating the requests for market specific requirements.
- Assessing potential regulatory impact of changes.
- Reviewing and approving eCCs impacting the company's vaccines.
- Liaising with Operations for the definition of implementation of changes and ensuring alignment with internal and external partners to minimise the impact on supply continuity.
- Participating in relevant internal and external meetings such as the Regulatory Project Team meetings, Implementation Committees, Technical Team meetings, etc.
- Managing internally and externally, such as between colleagues from different departments.
- Updating the company tracking tool (OPAL) in a timely manner and sending out weekly OPAL reports to all stakeholders.
- Interacting with external partners on their regulatory tracking tool.
Skills and Requirements:
- A university degree in a Scientific or Engineering degree, such as Chemistry or Biochemistry.
- An excellent understanding and knowledge of regulatory procedures and systems, such as Opal or CTD section (Module 3).
- A thorough knowledge of regulatory procedures and systems in RA or site conformance.
- Demonstrable experience in (Bio)pharma, cGMP, QA, Project Management, and Technical Lifecycle.
- An ability to identify and follow up on gaps in process, along with working under pressure due to the requested flexibility and reactivity of the activities.
- Being capable of managing short term issues with long term activities in parallel.
- Strong interpersonal skills, including communication, negotiation, networking, persuasion, and management.
- Developing a networking relationship across the company and external partner organisations.
- Fluency in verbal and written English.
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 Zico Dervish on +44 203 319 3031 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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