Regulatory Affairs Manager

3 weeks ago

Dublin, Dublin City, Ireland Besins Healthcare Full time

2 days ago Be among the first 25 applicants

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Recruitment Officer at Besins Healthcare

About Us

We are a pioneering, family-owned pharmaceutical company dedicated to advancing the development and global commercialization of reproductive hormone therapies that support the lifelong health and well-being of both men and women. To complement our core offerings, we also provide high-quality food supplements and medical devices.

Our products are widely used in gynaecology, fertility, obstetrics, and endocrinology. 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 continued success is built on attracting exceptional talent and fostering a collaborative, growth-focused environment.

Position:

We are seeking an experienced Regulatory Affairs Manager to lead EU regulatory operations and manage global marketing authorisation applications (MAAs), new product development, and lifecycle management activities across the Besins Healthcare portfolio. This role includes direct line management responsibilities.

Key Responsabilities :

  • Evaluate and propose the most appropriate regulatory strategy for new product development and life cycle maintenance of Besins Healthcare products for global markets.
  • Provide effective leadership and mentorship to a team of regulatory affairs professionals.
  • Preparation and filing of regulatory submissions for new marketing authorisations and life cycle management, including labelling updates, renewals, MA transfers etc., review of documentation, and publishing as relevant
  • Provide input on impact of new change controls on licences in global markets and facilitate implementation of these as relevant
  • Maintain clear, high-quality communication with internal teams (Quality, Medical, Clinical, Supply Chain, PMO, Pharmacovigilance, Industrial, Legal, and local RA managers) and external stakeholders.
  • Prepare status reports and metrics for assigned projets
  • Promote best practices in regulatory operations and the use of digital regulatory platforms.
  • Ensure regional regulatory experience and opportunities, obtained through regular regional contacts and collaboration, is fed back into relevant regulatory strategies

Job Requirements:

  • Several years of regulatory affairs and direct management experience
  • Scientific degree at Master of Science level
  • Strong leadership and team management skills.
  • Excellent organizational skills with the ability to manage multiple priorities.
  • Ability to communicate efficiently with internal and external stakeholders globally

Interested? Please apply

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionManufacturing
  • IndustriesPharmaceutical Manufacturing

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