Strategist / Senior Strategist - Regulatory Affairs

India·Bangaloresenior

Legal & ComplianceRegulatory

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Quick Summary

Key Responsibilities

Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio.

Requirements Summary

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,

Technical Tools

Legal & ComplianceRegulatory

Responsibilities

~2 min read

→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

Requirements

~1 min read

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.