Interim Regulatory Affairs Director Frbnl
il y a 3 jours
**Portfolio Responsibility**: Healthcare products (medicines, medical devices, cosmetics, food supplements) and consumer products (Biocides)
**Reports To**: Southwestern Europe Regulatory Head
**Role Purpose**:
The Regulatory Affairs Director FRBNL at Reckitt Health is responsible for ensuring the management and the development of the team and the coordination within the countries.
He is responsible for maintaining the MA’s portfolio up-to-date and coordinating the national registration phase.
He embodies the company towards the Health Authorities and any official bodies in charge of Health.
The QUALIFIED PERSON (QP) at Reckitt is, as required per the regulation (CSP art. 5113-2), GENERAL MANAGER (GM) responsible for the organisation and the control of all pharmaceutical operations and activities in relation with the marketing and sales of medicinal products: supply, distribution, products quality, promotion, scientific and medical information, batch recall, shortage, security feature, pharmacovigilance )
The QP participates to the R&D program for EPD’s and NPD’s.
The QP is responsible for ensuring that the health products on the market are of safe and of high quality.
As GM, the QP is a member of the Executive Committee and participates to the meeting and decision.
The QP is responsible to ensure that all activities linked to the medical reps activities and each people in charge of information and promotion of reimbursable medicinal products vis à vis of the healthcare Professional are in compliance with the Medical Reps Chart.
- Participate to the strategy on the healthcare portfolio
- Elaborate and implement the organization of the team in consistency with the organization of Reckitt
- Relay internally the strategic vision of Reckitt, and its values
- Represent Reckitt vis a vis of third parties as Health Authorities, subcontractors
- Insure that all the activities of Reckitt are in compliance with the pharmaceutical regulation, French and European, and with the current BMS (Business management System)
- Ensure compliance with the Code of Conduct, the anti-corruption law, the safety and health at work Policy, safety of products policy
- Be in membership with the main local association or trade union (AFIPA, leem, SNITEM )
- Ensure the compliance with any local and European regulation concerning Health products (drugs, medical devices, cosmetics)
- Supervise the Regulatory and Medical Affairs team including the Vigilance activities
- Ensure the quality of the Healthcare products including medicines, medical device, and cosmetics
- Efficiently contribute to the continuous improvement process of the quality of the information and practices of the medical reps according to the Chart
**Equality**:
In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.
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