Position Overview
We are seeking a highly motivated Regulatory Affairs Officer to join our Regulatory Affairs 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. You will work closely with regulatory authorities, internal stakeholders, and external partners to ensure the smooth lifecycle management of our pharmaceutical products.
Key Responsibilities
* Interact with regulatory authorities (EMA, EU and non-EEA National Competent Authorities) relevant to the Marketing Authorisations (MAs) granted to Helsinn Birex Pharmaceuticals Ltd and to Helsinns partners.
* Prepare MAA dossiers for new applications, variations, renewals, or other post-authorisation activities, in compliance with European regulations.
* Reply to the requests from the regulatory authorities (EEA and non-EEA) in conjunction with respective people based at Helsinn Birex Pharmaceuticals Ltd or at the Corporate Company (may include requests for legalised documents, Certificates of Pharmaceutical Product, samples etc.).
* Publish MAAs using Helsinns validated document management system and publishing software, and submission to the authorities in the relevant electronic formats.
* Ensure compliance is maintained between authorised MAAs and manufacturing site procedures.
* Regulatory evaluation of proposed quality, manufacturing, supply chain and CMO activities and change controls.
* Review and approval of product artworks to ensure compliance with the relevant MA.
* Interact with Helsinns Corporate office and Helsinn's partner companies and provision of documentation required to support the MAs they have responsibility for.
* Correspondence/maintenance activities with the HPRA in relation to HBPs Manufacturing and IMP authorisations and Active Substance Registration.
* Regulatory compliance activities relevant to the Helsinn Birex Pharmaceuticals manufacturing site, including review GMP documentation (specifications, analytical methods, batch records etc.).
* Clear communication of the regulatory status of Helsinns products to internal and external stakeholders through maintenance of compliance dossiers and circulation of Notices of Regulatory Approval/Event.
* Cooperate with Corporate Regulatory Affairs to attain Corporate objectives.
* Contribute to continuous improvement initiatives within Regulatory Affairs. Adhere to company policies, cGMP, EHS, and quality standards.
Required Qualifications And Experience
* Bachelors degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
* Minimum 1-2 years of experience in pharmaceutical regulatory affairs, preferable with a focus on CMC (Chemistry, Manufacturing, and Controls) activities.
* Familiarity with GMP and quality systems in a pharmaceutical manufacturing environment.
Key Competencies
* Strong attention to detail and organisational skills.
* Excellent written and verbal communication skills in English.
* Ability to work independently and collaboratively within a team.
* Ability to manage multiple tasks and deadlines while maintaining high-quality standards.
* Commitment to confidentiality, compliance, and ethical conduct.
* Flexible and responsive to changing regulatory requirements and business needs.
Skills
Regulatory Affairs CMC Marketing Authorisation Applications Pharma GMP Pharmaceutical Regulations
Benefits
Health Insurance Performance Bonus Pension Scheme Parking Space with EV Charger Flex Time Work from Home Scheme