Regulatory Affairs Officer
The department activities involve global regulatory initiatives and regulatory activities linked to the manufacturing site. The core activities of the Corporate regulatory group are the development of new therapies in the cancer support and worldwide registration of these new products.
- Maintenance of approved marketing authorisation (MA) dossiers through submission of variations, renewals, follow-up measures and PSURs
- Preparation of the above submissions in collaboration with other departments and partner companies
- Preparation of responses to regulatory authority queries
- Publishing of regulatory submissions using NextDocs and eCTD Manager software
- The Regulatory Affairs Officer will review and approval of product artworks to ensure compliance with the relevant MA
- Interactions with Corporate office and partner companies and provision of documentation required to support the MAs they have responsibility for
- Maintenance of manufacturing licence and Active Substance Registration by submission of any necessary variations to the HPRA
- Regulatory compliance activities relevant to the manufacturing site, including review of change controls and GMP documentation (specifications, batch records etc.)
- The Regulatory Affairs Office will provide clear communication of the regulatory status of products to internal and external stakeholders
- BSc in a life sciences discipline with 1-2 year’s work experience in pharmaceutical Regulatory Affairs.
- A working knowledge of European pharmaceutical regulations, Directives and guidelines.
- Applicants with less regulatory experience holding a post-graduate qualification in Regulatory Affairs, or with substantial experience in a Quality/CMC role may also be considered
- The next Regulatory Affairs Officer should also demonstrate excellent attention to detail.
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