About this role
Responsibilities:
- Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio.
- Supports the team with regulatory strategies (local and regional) that are in line with the business plan
- Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to:
Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand)
- Supports ad hoc projects (e.g., compliance reviews, audit preparation etc.)
- Signs off on packaging material, leaflets, and SmPCs (as appropriate)
- Supports the compilation of the Northern Cluster team metrics for the EMEA biannual metrics report
- Supports all regulatory activities in Malta
- Ensures regulatory compliance within the department to include:
The maintenance of global, regional, and local databases
- Adherence to processes, SOPs, work instructions, and job aids
- Updates to relevant local and global databases to track current product information
- Supports team with Calls for Information (CFI) and assist in any Pharmacovigilance- related activities within the Northern Cluster, which may include:
Receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues
- Ensuring responses are submitted in a timely manner and that they are in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory
- Provide support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox
- Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate.
- Ensures regulatory compliance within the department
Experience/Qualifications:
- Bachelor's/Master's degree in Life Science/Pharma
- Minimum of 5 ~ 8 years of relevant work experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience of CMC, Quality, or Regulatory Operations.