Regulatory Affairs Executive

ABOUT THE JOB

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Regulatory Affairs Executive to join Norgine. The person holding this position will report to the Regulatory Affairs Manager France, and be a member of the Global Regulatory Affairs department.

The Regulatory Affairs Executive is responsible for keeping oversight of regulatory submissions & support communication with regulatory authorities in order to expedite approval of these submissions with guidance or assistance as required. The Regulatory Affairs Executive to contribute to the growth and expansion of Norgine’s business through interaction with local teams within the Launch, Growth, Managed and Consumer Health Business Units.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

Requirements

KEY RESPONSIBILITIES & ACCOUNTABILITIES

• To support all product launches, new formulations, integrations for countries in scope
• To contribute to oversight of regulatory submissions and approval and artworks for France, Belgium, Luxembourg and Netherlands
• To support communication with regulatory authorities in order to expedite approval of submissions, both independently and as directed by the line manager
• To resolve straightforward regulatory issues and to assist in the resolution of more complex issues under supervision
• To participate as appropriate in project teams
• To identify and provide information for incorporation in the Regulatory databases as appropriate (i.e Vidal, CIP)
• To provide information on expenditure against the budget for inclusion in periodic financial reports
• To maintain the paper and electronic filing systems for assigned products/countries, following Records Retention procedures
• Where Regulatory input is required by local law or codes; support promotional compliance with legislation and relevant internal/external codes within France
• To support local MAPA activities in review and submission of price and reimbursement dossier
• Contribute to regulatory Intelligence activities
• To support Pharmacien Responsable in the oversight of activities specifics to France (e.i sales resp certification charter, exploitant training etc…)
• To interact with industry trade associations and external consultants as necessary

SKILLS & KNOWLEDGE

• Previous regulatory experience or experience in the pharmaceutical industry and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP) would be an advantage
• A good understanding of the drug development process
• Awareness, understanding and an ability to interpret the ICH guidelines relevant to his/her technical/functional responsibilities, specifically for those related to developing a Target Product Profile and delivering a product at the end of the development process
• Demonstrates a good ability to analyse data
• Focuses on customer needs, follows up on commitments and requests
• Good interpersonal skills
• Excellent verbal and written communication skills
• Works cooperatively within a team
• Ability to communicate clearly in English
• Pharmacists that can be registered to the Chamber of Pharmacists in France with an RA master or equivalent

Benefits

Benefits vary between locations.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.