Strategist / Senior Strategist - Regulatory Affairs

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