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 mate