Regulatory Affairs
Il y a 6 mois
locations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00010928- For our office in Zaventem, Zoetis is currently looking for a _Regulatory Affairs & Compliance, Associate Manager / Manager._
- JOB PURPOSE:
- In collaboration with the RA team members, the RA&C Associate
- Mgr / Mgr contributes to the Regulatory day-to-day tasks, business organization, specific projects.
- The RA&C Associate
- Mgr / Mgr contributes and optimizes - efficiency/timing - the portfolio maintenance in managing all the Regulatory legal obligations (including all submissions types)
- The RA&C Associate
- Mgr / Mgr implements and adapts the Regulatory & Compliance (Corporate and Regional) strategies to the markets.
- The RA&C Associate-Mgr / Mgr provides high quality Regulatory expertise and advises the Benelux Regulatory & Compliance Director, the EU Regulatory Affairs team (VMRA) and the Commercial Operations in supporting the teams to succeed in achieving commercial and financial objectives in compliance with ethic and integrity.
- With the other Regulatory team members, the RA&C Associate-Mgr / Mgr is one of the Regulatory contact persons with the Medicines Authorities (CBG/FAGG ) and the industry lobby (FIDIN/Pharma.be) to maintain and develop the Zoetis external network.
- With the Regulatory team, the RA&C Associate-Mgr / Mgr is one of the Benelux Pharmacovigilance local representatives and one of the contacts point for the business: for Zoetis colleagues as well as for the NCAs.
- The role of the RA&C Associate-Mgr / Mgr may require alternate presence at Zoetis Capelle in the Netherlands and at Zoetis Zaventem in Belgium and occasionally - depending on the needs/meetings - to travel within the Benelux region/Europe.
- CORE RESPONSIBILITIES:
- Regulatory Affairs:
- With the other Regulatory team members, conduct and contribute to various regulatory activities (inclu. artworks) related to Zoetis portfolio maintenance in obtaining and evergreening registrations and renewal processes in accordance with the relevant (EU/national) regulations.
- In addition of the regulatory daily activities, the RA&C Associate-Mgr / Mgr should be prepared to support the team with special obligations/requirements and specific projects and to provide related regulatory analyses/support for these activities (ex. claims management, technical expertise, special batch release, scientific advice, clinical trial, deviations management/documentation, tender, certifications )
- The role of the the RA&C Associate-Mgr / Mgr also includes involvement and contribution in different activities related to regulatory reporting, processing, and monitoring in providing all the relevant needed information/analyses - both internally and externally - so that Zoetis always complies with every regulatory legal requirement (ex. databases maintenance, procedures edition-review, packaging compliance, transparentie register, PhV reporting, advertising compliance control, audits/inspections support ).
- The RA&C Associate-Mgr / Mgr needs to have/acquire expertise in National/EU Regulatory legislations (including the NVR) for medicines and other Zoetis types of registered products.
- Business Support:
- The RA&C Associate-Mgr / Mgr needs to develop an internal and external network to proactively provide Regulatory knowledge and insight (Business intelligence and information management) about products, customers, competition, legislation and the ‘market in general’ in capturing/reporting every information of added value for business strategic planning and decision-making.
- The RA&C Associate-Mgr / Mgr contributes to good information exchange and communication with all the Benelux colleagues and Zoetis stakeholders in general. He/she answers questions and provides regulatory support/recommendations (qualitative expertise in regulatory affairs) to colleagues when needed.
- She/he establishes connections with Zoetis relevant teams (BUs, SCL, Quality, GMS, VMRD&A...) to contribute to market and business development in compliance (example: being involved in projects, minimizing stock issues )
Pharmacovigilance:
- With the Regulatory team members, he/she is one of the Pharmacovigilance local representatives and contact points for Zoetis colleagues and the national authorities
- She/he provides support in monitoring PVWorks entries and he/she generates a weekly/monthly report to the EU PV team in Zaventem.
- Once proven experience he/she may be requested to assist the team with PhV audits and inspections.
- She/he generates a monthly report of PhV cases for the Regulatory Affairs & Compliance Director
- He/she supports and makes recommendations to the business technical colleagues in case of PhV questions and/or PVWorks entries issue
- Compliance:
- She/he contributes to maintain Regulatory/PhV databases, documentation and archives to the company standards and legal obligations.
- He/she supports and guides the Business team through Complia
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