Offre d'emploi : Regulatory Affairs Manager - Pharmaceutical Industry - OTC

Recruteur
Michael Page
Région
Louvain-La-Neuve
Salaire
Negotiable
Publication
mardi 9 février 2021
Date limite
vendredi 26 mars 2021
Réf
JN -012021-2002259
Contact
Charles Jean
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
  • 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.

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