Regulatory Affairs Specialist - OTC Products

• Regulatory Affairs Specialist - OTC Products
• Global FMCG & OTC company

Client Details

Our client is one of the main actor within the FMCG & OTC world. In order to sustain their growth, they are today looking for a new regulatory affairs specialist in order to take care of the Regulatory Authorities on the Belgian Markets for their range of products.

Description

The successful candidate will have the following responsibilities:

• Manage all regulatory activities needed to obtain Marketing Authorizations (MAs) and other authorizations for all medicinal and non-medicinal products (e.g. medical devices, food supplements, cosmetics).

• Support Portfolio in the assessment of new ideas.

• Prepare the regulatory strategy for product registration with the support of the Central RA team.

• Manage all product (Medicines and non - medicines) life cycle, including variations, renewals and other local requirements (ex. Sunset clause if applicable).

• Manage via Corporate systems all the activities needed to ensure full compliance of labelling and artworks, according to local/European requirements and Company standards.

• Revision and clearance via Corporate systems of advertising materials to ensure full compliance with local/European regulatory requirements, internal data, documentation and processes.

• Prepare and submit all Pricing applications.

• Provide Budget estimate for each Fiscal year and keep control of the expenses.

• Interact with Ministry of Health and other Regulatory Authorities for above activities creating and fostering a network of contact to facilitate dialogue during regulatory procedure. Represent the MA Holder (MAH) in all matters relevant to medicinal products and other Personal Health products (e.g. medical devices, food supplements, cosmetics), including regulatory questions, issues and crisis.

• Ensure full compliance to national/ European regulations, Company standards and SOPs of all marketed products.

• Accurate maintenance of Corporate System and Databases for products information, data and documentation.

• Coordinate any consultancy or outsourced support

• Keeping up to date on and interpreting national and international RA legislation and regulations.

• Participate in RA related meetings and execute action points

• Be a member of the local Crisis Management Team when necessary

Profile

The successful candidate will have the following requirements:

• Minimum a Master Degree within a Life Sciences orientation
• At least 1 year experience in a similar - RA oriented - role
• Fluent in Dutch, French & English

• Demonstrated managerial skills, specially having a strong track record of success as a leader or agent of change and ability to lead multiple projects.

• Strategic focus: can identify emerging issues and coordinate with business leaders.

• Very strong communication skills, Very strong networking/relationship. building/interpersonal capabilities.

• Experience in handling corporate crisis management and issue resolution.

• Exceptional collaboration and teamwork skills. Comfortable in working in a matrix organization with multiple partners, stakeholders and customers

• Proven ability to rapidly acquire knowledge and understanding of therapeutic categories, analyze scientific and clinical data/information, translate data/information into business relevant language and messaging.

• Ability to integrate technical and commercial thinking and priorities.

• Demonstrated ability to handle competing priorities effectively.

• Self-initiator, versatile and assumes risk with responsibility.

Job Offer

The successful candidate will have the chance to join one of the major organisation within the OTC world & an attractive salary package in line with his experience.