About Us
We are a family-owned company founded in 1885, pioneers in the development of transdermal hormone gels. Today, we focus our expertise on gynecology, fertility, pregnancy, as well as treatments for hormonal imbalances in both women and men. We are fully dedicated to advancing reproductive hormone therapies that support the lifelong health and well-being of both women and men.
With a presence in over 90 countries through a strong network of subsidiaries and distributors, we continue to grow sustainably. Today, we operate with approximately 1,500 employees, 22 subsidiaries, and 5 manufacturing sites. Our multicultural team operates across four corporate sites in different countries.
Purpose of the job:
Manage marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for Besins Healthcare portfolio of pharmaceutical products. Promote and lead by example for high quality regulatory best practices, process efficiencies, effective communication, planning and delivery of GPA and Corporate projects
Key Responsabilities
Act as a reference and contact person for the product(s) and countries under your responsibility. Ensure good communication flow with relevant affiliates, partners and other departments as relevant.
Timely and relevant input provided to stakeholders internally and externally.
Prepare the regulatory strategy for registration of medicinal products in region/country of responsibility in collaboration with local contact(s) as relevant. Maintain overview of registration planning short-term/middle term.
Propose and provide proactive input to regulatory submission strategies for product(s) and countries as relevant. Maintain overview of product status by country in area of responsibility.
Prepare and file submissions including: life-cycle maintenance variations, initial MAA fillings, labelling updates, renewals, marketing authorisation transfers.
Regulatory submissions made on time.
Act as mentor and/or contact person for students and junior or external team member(s) as relevant.
Sharing of good practice and knowledge with team members, good flow of information.
Promote best regulatory practice and approach in business operations within GPA and cross-functional teams.
Ability to influence and partner with cross-functional teams in a global pharmaceutical organisation.
Promote best regulatory practice for efficient change control handling and finalisation.
Ability to influence and partner with cross-functional teams to ensure timely and efficient preparation, review and sign-off on change controls in area of responsibility
Job Requirements
* Scientific, pharmaceutical, or Regulatory Affairs degree 3+ years and proven track record of successful Regulatory Affairs experience Experience in non-EU international markets
* Good knowledge of CTD Module 1 to 5 dossiers and requirements for different types of submissions
* Strategic mindset for submission planning and local labelling opportunities
* Ability to multi-task
* Clear and efficient communication skills across topics and regions
* Autonomous, good organisational and time management skills