Regulatory Affairs Manager - Pharmaceutical Industry - OTC
- Employeur
- Michael Page
- Lieu
- Louvain-La-Neuve
- Salaire
- Negotiable
- Date de clôture
- 26 mars 2021
Afficher plus
- Fonction
- Enseignement / Recherche / Sciences
- Secteur
- Sciences - Recherche / Développement, Pharmacie
- Type de contrat
- CDI
- Temps de travail
- Temps plein
- Niveau d'expérience
- 5 à 10 ans d'expérience
Détails de l'offre
- Regulatory Affairs Manager - Pharma OTC - Belgium
- Market leader organization with multiple launches ongoing
Client Details
Our client is a leading OTC pharmaceutical organization that work toward the health professionals & the patient in order to help them in their daily health management.
In order to sustain their growth in Belgium, they are currently looking for a new Regulatory Affairs Manager to take care of the operational & strategical approach of the RA activities.
Description
As the successful Regulatory Affairs Manager, you will have the following responsibilities:
- Participate to the development and implementation of worldwide regulatory strategies for products under development and life cycle maintenance for products on the market.
- Ensure efficient coordination with Global Regulatory Affairs and other internal key stakeholders such as CMC/Quality, non-clinical & clinical teams to meet business objectives.
- Drive the local regulatory representative activities regarding the registration activities (National, MRP/DCP) and Advertising & promotional activities.
- Will participate in DCP/MRP strategy when BEL is RMS / CMS
- Shape the Regulatory environment in particular new local regulations and EU regulations impacting Belgium and Luxembourg activities.
- Develop and maintains strong relationship with national competent Health Authorities (Be/Lux)
- Participate to regulatory due diligence assessments and recommendations for acquisitions, partnering and product distribution.
- Develop & implement Belgian policies and procedures to enhance operation of the department and ensure overall regulatory.
- Provide guidance, interpretation and opinions on complex regulatory matters outlining the different outcomes.
- Ensure that product labelling and promotional materials are in compliance with local regulations.
- Provide technical leadership, training and vision by interpreting regulatory affairs initiatives.
- Contribute to the organizational design of the regulatory affairs function and leads the selection of resources required to meet departmental and corporate objectives;
- Support the coordination of contracted activities and contact with local & competent Health Authorities.
- Manage local service providers.
- Proactively identifies opportunities for process improvements.
- Represent Corporate Regulatory Affairs with the senior management Belux committees.
- Perform other tasks and assignments as needed and specified by management.
- Has to be on the list of Responsible person for Information and Publicity (medical information)
Profile
As the successful Regulatory Affairs Manager, you will have the following requirements:
- Master's degree in Pharmaceutical Sciences / Pharmacist with complementary Industrial Pharmacy Degree
- Being enrolled on the list of the Agency
- At least 5 years of successful experience in Regulatory Science and Quality Assurance experience in a pharmaceutical industry.
- Very good understanding in Regulatory, Supply Chain, Quality Control and/or Quality Assurance within the industry.
- Direct contact and negotiation experience with Belgian & Lux competent authorities
- Demonstrated track record of success building relationships with, and influencing, national health authorities, particularly in situations requiring direct interaction/negotiation.
- Ability to influence without direct authority.
- Good negotiating and interpersonal skills, as well as an excellent verbal and written communication
- Fluent in French & English - Dutch is a strong asset
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Prior experience as main RP or Deputy RP, including releasing of batches onto the Belgian market would be consider as a plus.
Job Offer
The successful Regulatory Affairs Manager will join a fast growing leader in its market. The candidate will have an attractive complete salary package in line with his experience.
Entreprise
At the heart of our business are the thousands of people’s lives we change, the outstanding service we provide to our clients and candidates and the exciting opportunities within our offices all over the world. We’re proud to set the standard in the recruitment profession – our specialist service with a personal touch is how we change lives for people through creating opportunity to reach potential.
As an employer looking to hire, or a candidate aiming to grow your career, Michael Page offers you a team who understand your market, backed by the resources and expertise of a global network.
We specialise in the following disciplines: Banking & Financial Services - Engineering & Manufacturing – Finance - Healthcare & Life Sciences - Human Resources - Information Technology - Interim Management - Procurement & Supply Chain - Sales & Marketing - Tax & Legal
Together with Page Personnel, Page Executive and Page Outsourcing, Michael Page is part of PageGroup. We’re confident that our expertise will help you meet your recruitment or job search goals. Get in touch to find out more.
- Website
- http://www.michaelpage.be/index.html
- Téléphone
- 02/290 97 26
- Lieu
-
Marsveldplein (Bastion Tower) 5
Brussels
1050
BE
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