Regulatory Specialist
We are seeking a highly motivated Regulatory Specialist to join our team at Helsinn Birex Pharmaceuticals Ltd, based in Dublin 15. In this role, you will support the management and maintenance of Marketing Authorisations (MAs) in compliance with European and international regulations.
About the Role
In this position, you will work closely with regulatory authorities, internal stakeholders, and external partners to ensure the smooth lifecycle management of our pharmaceutical products.
* Prepare and submit Marketing Authorisation Applications (MAAs), variations, renewals, and post-authorisation activities in line with European regulatory requirements.
Required Skills and Qualifications
Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline. Minimum 5 years of experience in pharmaceutical regulatory affairs, with a focus on CMC (Chemistry, Manufacturing, and Controls) activities.
Benefits
We offer a range of benefits including:
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