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.