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Regulatory Affairs Lead
Carries full accountability for regulatory approvals (including clinical trials and early access programs) and for managing the registration files for medicinal products/medical devices.
Influences changes in RA and drives pro-active implementation.
Provides independent tactical/scientifically related guidance cross-functional on aspects of RA.
Acts as the link between the company, its products, and the regulatory body.
Ensures Medical Information process in the MC is compliant with local legislation and the company’s processes and provides oversight of the External Service Provider appointed for providing Medical Information Services to the Belux MC
Act as GRP Quality Lead in the MC in line with Quality Management for GXP Activities in Commercial – SET.
The Regulatory Affairs Lead operates in the Belgian and Luxemburg markets.
YOUR KEY RESPONSIBILITIES
In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:
Manages and develops the RA team
- to ensure execution of regulatory plans including product/medical devices launches, product divestments and acquisitions
- to ensure adequacy between the team’s competencies and the needs related to the Business and the current and future portfolio
- Responsible for regulatory submissions (including clinical trials and early access programs) on new and established products/medical devices supporting rapid and high-quality approval in close cooperation with European & Global Regulatory Affairs and implementation of regulatory files on the Belux markets.
- Proactively contributes to the local implementation of the registration strategy at all lifecycle stages of a drug/medical device.
- Supports cross-functional brand-teams with expert regulatory advice; gives regular updates to the brand team.
- Identifies potential regulatory risks related to our products/medical devices and proposes options to mitigate risks, including the coordination of the local risk minimization activities.
- Acts as local contact for authorities, in all regulatory affairs related matters.
- Builds network and partnerships with pharma associations, healthcare authorities and decision makers (pharma.be and other relevant associations) and participates actively in working groups, representing the company’s interests.
- Acquires competitive intelligence in order to facilitate decisions with regards to labelling and registration files.
- Fulfils the role of local GxP quality lead for Good Regulatory Practices (GRP) in the Belux MC in line within line with Quality Management for GXP Activities in Commercial - SET, and with Good Regulatory Practice (GRP) in the company.
- Supports market access teams with expert regulatory advice; gives regular updates to the market access team.
- Supports Operations through Demand Planner and MCAM to ensure drug supply on Belux markets and manage drug supply issues
- Support Quality Assurance with expert regulatory advice
- Act as Back-Up Local Recall Administrator (Product Quality Issue management), incl. counterfeit responsible
- Manage the set-up of Early Access Programs in the MC
- Be responsible for RA budget
- Providing, as an expert, strategic support on collating and distributing medical information for all company’s drugs.
- Monitor important performance matrix on quality, completeness, and timeliness, identify opportunities for improvement and organize and lead improvement initiatives.
- Ensures accurate, well balanced, and fair medical responses are given by MSLs to complex queries (3rd line) to internal/external customers in a timely manner and the replies are documented into GMIP.
- Prepares and updates the local processes for handling, documentation and answering of medical enquiries.
- Ensures the requirements as set forth in the Annual Medical Information Checklist are documented and communicates this checklist in due time to Global.
- Puts in place the Quality management of medical information processes.
- Detects and develops opportunities to use of new channels into Medical Information
- Ensures integration of Global MI standards and procedures in local practices
- Be one of the local contact persons for the External Service Provider (ESP) and ensures they receive adequate guidance and support (local FAQs, accurate leaflets) in order to allow them to answer to 1st line MI enquiries on behalf of the company’s MC Belgium.
- Super-user in the company’s global medical information platform (tracking tool for Medical Inquiries), GMIP.
- Perform quality checks as described in local SOP.
- Maintain the local repartition list up to date.
- Work together with External Service Provider for MI to meet the requirements set in the local MI procedure.
For a temporary period, the RA Lead will ensure management of the Qualified Person / Responsible Pharmacist (QP/RP), including the follow-up of the QA budget.
LEADERSHIP AND FUNCTIONAL CAPABILITIES
- Exemplify the company’s Values and behaviors (see annexe)
- Team leadership
- Developing others
- External awareness
- Decision making
- Quality orientation
- Sense of urgency
- Technical credibility
- Business Acumen
- Significant experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension and license maintenance, or experience at a health authority
- Strong negotiation and influencing skills
- People management experience
- Project management skills
- In depth knowledge of regulatory affairs legislations/obligations
- Trilingual: French, Dutch and English
- Insights in the broader health economic environment
- Registered as Qualified Person
- Experience in Quality Assurance
KEY RELATIONSHIPS TO REACH SOLUTIONS
- Medical Director
- Patient Safety, Nominated Signatory, Site Monitoring and Management Team (SMM), RWE, Medical Affairs, Business Units, Market Access, IBEX team, Finance
- Demand Planner, MCAM, Customer Service, Distribution Manager
- Global Regulatory
- Belgian & Lux. Health Authorities
- Stakeholder associations (eg. Pharma.be, APB)
- BRAS (Belgian Regulatory Affairs Society)