For one of our clients located in the Walloon Brabant, we are looking for a RA Compliance Expert Transition Team.
- Do you have a Scientific/Engineering degree (Chemist or Biochemist)?
- Do you have previous experience with regulatory procedures/systems/guidance (CTD section, module 3)?
- Are you fluent in English (spoken and written)?
Then, you might be the candidate we are looking for!
The mission of a RA Compliance Expert Transition Team is to manage Regulatory activities and to interact with external collaborators. The regulatory oversight and the alignment of the operations to the approved data by 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 its clients.
Therefore it is very important that you clearly understand the pharmaceutical business and that you have knowledge of Regulatory Affairs as well as some technical background.
1. CMC/Regulatory Affairs activities
- You have to liaise between the GRA organization and the Manufacturing Performance Unit on regulatory compliance matters including deviations and change controls
- You are the Single Point of Contact (SPOC) for any topic related to Regulatory Affairs
- You have to follow-up the MA (marketing authorization) and the regulatory life-cycle activities in Europe and Worldwide
- You have to ensure that the licenses are maintained in compliance with regulatory requirements worldwide
- You have to review and to approve all source documentation supporting CMC variations
- You efficiently follow-up the responses to any questions and respect the timings of the projects
- You maintain close contacts with the Local Operating Company’s in the countries where the company is still MAH
- You identify 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 management to solve the problem.
- You coordinate questions & answers and commitments to external partner and to BOH (Boards of Health)
- You contribute to prepare and review the PQR (Product Quality Review)
- You coordinate the requests for market specific requirements
Note that this role does not include any CMC writing as this is done by the external partner.
2. Change Controls
- You initiate the assessment of the potential regulatory impact of change
- You review and approve eCCs
- You liaise with Operations for the definition of implementation and release strategy
- You follow the submission, approval, and implementation of changes and ensure alignment with internal and external partners to minimize the impact on supply continuity
3. Key Interactions
- You participate in relevant internal and external meetings such as the Regulatory Project Team meetings, Implementation Committees, Technical Team meetings, etc
- You are able to manage internally (between colleagues from different departments) as well as externally.
- You update in a timely manner the regulatory tracking tool (OPAL)
- You send out weekly OPAL reports to all stakeholders
- You interact with the external partner on their regulatory tracking tool
- You have a Scientific/Engineering degree ( Chemist or biochemist)
- You have excellent understanding & knowledge of regulatory procedures/systems/guidances eg. Opal, CTD section (Module 3)
- You are fluent, spoken and written, in English
- You are autonomous and results-driven
- You are proactive with the ability to identify and follow up on gaps in the process
- You are able to work under pressure due to the requested flexibility and reactivity of the activities
- You are able to manage short term issues with long term activities in parallel
- You are able to work in project teams in a multidisciplinary environment and a matricial organization
- You develop networking relationship across the company and external partner organizations
- You are able to lead and manage cross-functional projects
- You have excellent communication and negotiation skills
- You have experience in regulatory procedures/systems/guidances - RA or site conformance
- You have experience in (Bio)pharma & cGMP
- You have experience in QA
- You have experience in Project Management
- You have experience in Technical lifecycle
+32 10 68 53 30