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.