Antwerp Metropolitan Area
General: - Ensure compliance of the local P&G Health product portfolio to applicable regulations, guidelines and internal standards. Especially focusing on pharmaceuticals, food supplements, cosmetics and medical devices. - Regulatory strategy: contribute to the development of the regulatory strategy by sharing Benelux point of view regarding all new initiatives (e.g. registrations of new products) and life cycle activities (e.g. variations, roll outs) and ensure submissions are done in due time. This includes keeping the RA database up to date to reflect the Life Cycle of the Benelux-products. - Regulatory Intelligence: advise the broader organization – both local and global stakeholders – on potential risks emerging from changing local legislation and act accordingly. - Review and ensure conformity of the product artworks and promotional material in line with local legislation, local codes and global procedures. - Strong interaction with the commercial organization. To advise organization of potential regulatory risks and recommend compliant actions. - Interaction with local Boards of Health (BoHs) and Trade Associations TAs: first point of contact, including strong relationship and present the interests of the organization, gain relevant information and help shape change. - GDPR Single Point Of Contact (SPOC). - Work in a compliant way including: Co-operation during internal audits, Inspection: including leading/attending inspections and execute CAPA plan, G-TRAQ (Change Control System), Working according to the Global SOPs and creating local SOPs when required Give strategic advice to both global and internal team with regards to: - Launch of new products - Development of promotional and non-promotional materials People responsibility: - Train/Mentor young RA colleagues depending on the working model or upon request of senior management.
REGULATORY AFFAIRS - Strategic regulatory advice in the registration strategy of new products/post-licensing activities in BeNeLux. - Planning and implementing variations (incl. national phase closures). HEALTH CARE COMPLIANCE - Reviewing and approving promotional and non-promotional activities. Responsible person for materials used in The Netherlands. - Reviewing and approving promotional and non-promotional activities. First line approval for materials used in Belgium. - Validating and approving translations of product information. (including Mdeon, CGR, KOAG-KAG) PACKAGING MATERIAL COMPLIANCE - Reviewing and approving product-related packaging. PHARMACOVIGILANCE - MEDICAL INFORMATION - Responsible person for PhV (BeNeLux). - Submission of Risk Management Materials (BeNeLux). - Handling inquiries from Health Care Professionals. - Experience in audits and writing/executing CAPA plans. MISCELLANEOUS - SOP writing. - Liaising with local Health Authorities. - Responsible for managing local RA budget. - Training of personnel. - Active within trade associations. - Close follow-up on new legislations, directives, ... - Member of Management Team, Ethics Committee, Compliance Committee, Price and Reimbursement Team.
Working as RA-manager, being responsible for products in the area of Cough&Cold and NRT (BeNeLux). I also participate in the review process of promotional material (BeNe).
- Submission of initial marketing authorisations and variations (eCTD format): DCP, MRP and NP. - eCTD expert - Readability testing