Company : Zoetis Location : Zaventem Flanders From : Talent BE
The RA&C Associate-Mgr / Mgr provides high quality Regulatory expertise and advises the Benelux Regulatory & Compliance Director, the EU RegulatoryAffairs 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 ZoetisZaventem in Belgium and occasionally - depending on the needs/meetings - to travel within the Benelux region/Europe.
CORE RESPONSIBILITIES:
RegulatoryAffairs:
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 regulatoryaffairs) 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 RegulatoryAffairs & Compliance DirectorHe/she supports and makes recommendations to the business technical colleagues in case of PhV questions and/or PVWorks entries issueCompliance:
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 Compliance.
She/he monitors compliance of artwork, promotional materials (CCV), pharmacovigilance.
Public Affairs:
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 networkWith experience, actively develop contacts with government, politics, professional organizations, and media – as/when needed collaborate with Corporate communication and Public Affairs.
Quality:
As one of the local quality deputy, the RA&C Associate-Mgr / Mgr has a contributing role in developing, maintaining the quality systems, participate to the relevant quality governance bodies and to be a contact person with the Zoetis GMS Quality organisation as needed to support the commercial business and the compliance obligations.KEY SKILLSCompliance and EthicHonesty and IntegrityGood team worker as well as ability to work in a relative autonomyGood analytical skillsGood verbal/written communication skills (including presentation skills)Detail mindedService-orientedAdaptation to changing environmentProactivityAble to work under pressureOur Colleagues make the differenceKeep your regulatory and compliance skills sharp.
Train, and retrainBe an expert on your solutions – know them inside and out, and continue to learnUse the experience from setbacks and failure to drive your future successAlways do the right thingPer his/her function, the RA&C Associate-Mgr / Mgr has key responsibilities in contributing/promoting compliance, he/she helps to build Zoetis reputation and need to meet legal obligationsCustomer obsessedThe RA&C Associate-Mgr / Mgr being one of the Regulatory contact persons with the Medicines Authorities (CBG/FAGG…) and the industry lobby (FIDIN/Pharma.be) he/she should develop and maintain a strong external network as the company representativeThe RA&C Associate-Mgr / Mgr is close to the commercial colleagues and brings them his/her experience and expertise to serve the best serve the customers with ethic and complianceRun it like you own itDeliver on your commitments to authorities and to colleagues.
Always do what you say you’ll do.We are one ZoetisGive the team timely information and support that helps them to deliver their roleCommunicate across roles, across countries, across departments/BU’sTRAINING & QUALIFICATIONSEducation:
Scientific degree in Veterinary Medicine.Basic knowledge in pharma Quality, Good Distribution/Manufacturing Practices (GMDP)Other specific know-how:
good knowledge of Word, Excel, PowerPoint, Outlook, and intuitive with the digital tools/social media.Languages:
Very good in Dutch, French and EnglishEXPERIENCEIdeally first experience in pharmaceutical regulatoryaffairs (including PhV) and compliance position.TRAVEL REQUIREMENTSThe role of the RA&C Associate-Mgr / Mgr may require alternate presence at Zoetis Capelle in the Netherlands and at ZoetisZaventem in Belgium and occasionally - depending on the needs/meetings - to travel within the Benelux region/Europe. Full time Zoetis ZaventemFlanders
