This company is dedicated to providing innovation and choice in women’s health, with a particular focus on fertility, contraception and menopause. Their goal is to develop new and improved products that meet women’s needs for better safety and convenience. The company also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO.
The company was founded in 1999 as a spin-off of the University of Liège and has an approximate headcount of 170 staff members.
What is your job?
We are looking for a Regulatory Affairs Leader to join the R&D Department at the company’s headquarter.
We are looking for a talented, experienced regulatory affairs expert to join the Regulatory Affairs team. Reporting to the Head of Global Regulatory Affairs, the RA leader provides support for the implementation and execution of regulatory strategy and health authority interaction, and coordination of regulatory submissions and post-approval life-cycle management with internal and external partners worldwide.
Duties & Responsibilities
The role may evolve with the new challenges however core responsibilities will include:
- Ensure marketing authorizations and lifecycle management are compliant with regulatory requirements.
- Define and/or coordinate the preparation of new submissions and variations and defining the regulatory strategy for submission worldwide.
- Manage European submissions (variations, renewals,…), assuring timely execution and compliance.
- Manage publishing, submitting and archiving of documents.
- Provide support to local partners for the preparation of local submissions, and assure timely execution and compliance.
- Review product labelling/packaging texts.
- Ensure timely and pro-active communication of the authorization status within the organization.
- Collaborate with internal and external stakeholders, including local Health Authorities when appropriate.
- Review the regulatory aspects included in contractual proposals with potential partners.
- Manage regulatory-related work/purchase orders.
- Build and sustain a positive relationship with the health authorities and local partners.
- Follow-up of regulatory legislation; evaluate impact on business.
- Provide regulatory requirements and intelligence to Regional and European organization.
Who is the candidate we are looking for?
- University degree – medical or paramedical (pharmacy, biology, veterinary, biomedical Sciences) or equivalent by experience
- Minimum 5 years’ experience in a similar function
- Experience with EU regulatory procedures (CP, MRP/DCP, NP) and post-marketing regulatory framework
- Experience in working in cross-functional project teams and within a collaborative team environment
- Excellent oral and written communication skills
- Excellent interpersonal, negotiation and communication skills
- Fluent in English and French (speaking, reading and writing)