Strategist / Senior Strategist - Regulatory Affairs

Overview

Supports regulatory strategy, submissions and compliance activities for products across the UK, Ireland, Malta, Sweden, Finland, Norway and Denmark within the Northern Cluster of ClinChoice's Regulatory Affairs function.

What you'll do

• Support the team with local and regional regulatory strategies in line with the business plan.
• Support regulatory activities for national and/or European procedures (Decentralized, Mutual Recognition) as appropriate.
• Prepare and compile regulatory submissions, responses to questions, renewals and post-submission/approval activities, including relevant updates to external websites such as emc, medicines.ie and In-Demand.
• Support ad hoc projects such as compliance reviews and audit preparation.
• Sign off on packaging material, leaflets and SmPCs as appropriate.
• Support compilation of the Northern Cluster team metrics for the EMEA biannual metrics report.
• Support all regulatory activities in Malta.
• Ensure regulatory compliance within the department, including maintenance of global, regional and local databases, adherence to processes, SOPs, work instructions and job aids, and updates to databases tracking current product information.
• Support the team with Calls for Information (CFI) and assist in Pharmacovigilance-related activities within the Northern Cluster, including receiving and monitoring CFI responses through liaison with UK and EAME colleagues, ensuring timely submission 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 the UK PV group or Global Reg Med Mailbox.

What you'll need

• Bachelor's or Master's degree in Life Science or Pharma.
• Minimum of 5 to 8 years of relevant work experience within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements), with direct accountability for deliverables, or a combination of direct Regulatory Affairs experience in CMC, Quality or Regulatory Operations.

Details

• Location: Bengaluru, Karnataka, India.