Head of Regulatory Affairs - Consumer Health
As Belgian Responsible Person, the Head RA assumes the responsibility for pharmaceutical activities in the framework of the Belgian regulations & guidelines.
- 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.
The successful candidate will have the following responsibilities:
- 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.
- 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.
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%
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.