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; 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, including the maintenance of global, regional, and local databases, adherence to processes, SOPs, work instructions, and job aids, and updates to relevant local and global databases to track current product information; Supports team with Calls for Information (CFI) and assists in Pharmacovigilance-related activities within the Northern Cluster, including receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues, ensuring responses are submitted in a timely manner and in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory, and providing support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox

Requirements

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