Head of Regulatory Affairs - Consumer Health

Recruteur
Michael Page
Région
Belgique
Salaire
Negotiable
Publication
mardi 2 juillet 2019
Date limite
vendredi 2 août 2019
Réf
568581/001
Contact
Charles Jean
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
  • As Belgian Responsible Person, the Head RA assumes the responsibility for pharmaceutical activities in the framework of the Belgian regulations & guidelines.

Client Details

  • Our client is a global leader on the Consumer Health market.
  • More than 50% of the market share in Belgium.
  • In order to sustain a strong development & to bring the organization to the next level, they are today looking for a new Head of Regulatory Affairs in Belgium.

Description

The successful candidate will have the following responsibilities:

QA/RP aspects:

  • Responsible for the direct technical supervision of the facilities.
  • Ensures the validation of the Good Medical Practice - GMP.
  • Decide to release or reject a batch, independently from the management of the company (having an authorization number to release batches).
  • Be the main contact point in case of inspections by relevant health authorities and supervises the relevant corrective actions related to inspections.
  • Coordinate and handle the external complaints for product released in Belgium based on quality defects or adverse drug reaction - competence to inform the national health authority accordingly.
  • Supervise the initiation, realisation and the evaluation of product complaints and batch recalls in Belgium.
  • Be responsible for the creation and administration of quality-relevant documents.
  • Ensure that the initial and continued training of the personnel is carried out.
  • Review and approve the Quality Agreements with third parties in Belgium.
  • Review and Approve the Annual Product Quality Report for the medicinal products.

Regulatory considerations:

  • 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 Corporate Regulatory Affairs and other internal key stakeholders such as CMC/Quality, non-clinical & clinical teams to meet business objectives.
  • Drive the local regulatory representative actives including Pharmacovigilance, Complaint management, Medical Information, Advertising & promotional activities.
  • Shape the Regulatory environment in particular new local regulations
  • Develop and maintain relationship with national competent Health Authorities.
  • Participate to regulatory due diligence assessments and recommendations for acquisitions and/or partnering and product distribution.
  • Develop & implement Belgian policies and procedures to enhance operations.
  • Ensure that product labelling and promotional materials are in compliance with local regulations.
  • Provide technical leadership, training and vision by interpreting regulatory affairs initiatives.
  • Manage local service providers.
  • Represent Corporate Regulatory Affairs on Board of Directors.

Profile

The successful candidate will have the following requirements:

  • Master's degree in Pharmaceutical Sciences
  • Enrolled on the list of the Agency with a minimum of 10 years of successful experience in Regulatory Science.
  • Minimum 5 years of leadership experience as a Head Regulatory Affairs role and as RP or Deputy RP.
  • Prior experience leading an associated staff.
  • Prior experience releasing of batches onto the Belgian market.
  • Demonstrated track record of success building relationships with, and influencing, national health authorities, particularly in situations requiring direct interactions and negotiations.
  • Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
  • Ability to influence without direct authority.
  • Good negotiating and interpersonal skills, as well as an excellent verbal and written communication.
  • Fluent in English, French and Dutch
  • 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.
  • Ability to travel up to 10%

Job Offer

The successful candidate will:

  • Have have the chance to join a global organization at a critical time of change & expansion.
  • Take part & write down the future success of the organization on a high startegic level.
  • Enhance a team with a high level of development opportunities.
  • have an attractive full salary package in line with his experience.