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


• 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.