Regulatory Affairs Manager - BeNeLux - Pharmaceutical Company
Regulatory Affairs Manager - OTC Products - DU/FR/EN
Qualified Pharmacist - Lead a team of 4 Regulatory specialist in BNL
Over onze klant
Our client is one of the main actor within the OTC world.
With a fast moving mindset and growing market shares in BNL, they are currently looking to reinforce their Regulatory Affairs team via the integration of a new Regulatory Affairs Manager.
Taken en verantwoordelijkheden
As the successful Regulatory Affairs Manager, you will have the following responsibilities:
- Lead and champion the Regulatory function within Benelux
- Manage a team of 4 Regulatory Specialists across Belgium
- Ensure the continued growth and development of the Regulatory Specialist team within Benelux
- Work collaboratively with Snr Management both within the Benelux, but also within the France/Benelux cluster in order to define and implement the regulatory strategy
- Create strong and proactive relationships with all partner functions.
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets and brands to enable the strategic delivery of a global pipeline.
- Maintain and develop knowledge and intelligence across the Regulatory Function to build 'right first time' approach with respect to registrations globally.
- Collaborate with partner functions to agree market specific data requirements and delivery timelines
- Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learning's to ensure efficient speed to market.
- Represent the business with external stakeholders
Actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment
As the successful Regulatory Affairs Manager, you will have the following requirements:
- At least a Master Degree in Pharmacy with a specialization within Industrial Pharmacy
- At least 3 years of experience within a Regulatory function.
- Relevant Regulatory experience and knowledge in dossier / technical file creation and global registrations.
- Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration.
- Experience in preparing and submitting dossiers, variations and renewals.
- Understanding of global product development practice, rules, regulations and guidelines.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- Ability to consistently deliver to time, cost and quality standards in a fast-paced environment.
- Ability to work on own initiative and be a self-starter.
- Excellent communication, influencing and stakeholder management skills.
- Strong team management skills.
- Fluent in French, Dutch and English is mandatory.
The successful candidate will:
- Have the opportunity to join a fast changing environment with a daily challenge in the Regulatory sector
- Lead an eager to learn & develop team
- Have an attractive salary package in line with his experience