Senior Regulatory Affairs Officer

4 weeks ago

Dublin, Ireland Besins Healthcare Full time

Overview
Recruitment Officer at Besins Healthcare
About Us
Besins Healthcare, founded in 1885, is a global, family-owned pharmaceutical company specializing in medical-grade hormones.
With expertise in gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments, we are dedicated to advancing reproductive hormone therapies that support lifelong health and well-being.
Our multicultural team of more than 1,500 employees, across 22 affiliates and 5 production sites, supports our presence in over 90 countries.
Together, we continue to grow through innovation, expanding our products into new territories, and building strong partnerships worldwide.
Responsibilities
Manage regulatory activities for Besins Healthcare's pharmaceutical portfolio, including marketing authorisation applications (MAAs), lifecycle management (variations, renewals, transfers), and submissions.
Develop and implement regulatory strategies for product registrations in assigned regions/countries.
Prepare, file, and track submissions (MAAs, variations, renewals, labelling updates, transfers).
Maintain oversight of registration planning and product status by country.
Act as main contact for products and regions, ensuring timely communication with affiliates, partners, and internal stakeholders.
Mentor junior team members and share regulatory best practices.
Support cross-functional teams with regulatory input, change control management, and process efficiencies.
Qualifications
Degree in science, pharmacy, or Regulatory Affairs.
3+ years of Regulatory Affairs experience, including non-EU international markets.
Strong knowledge of CTD Modules 1–5 and regulatory requirements.
Strategic mindset for submissions and labelling.
Strong communication, organisational, and multitasking skills.
Ability to work autonomously and collaboratively across global teams.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Pharmaceutical Manufacturing
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