Offre d'emploi : Head of Regulatory Affairs - Consumer Health

Recruteur
Michael Page
Région
Belgique
Salaire
Negotiable
Publication
lundi 29 juillet 2019
Date limite
jeudi 12 septembre 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.