Senior Associate

2 weeks ago

Bengaluru, Karnataka, India ClinChoice Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Responsibilities:

  • Supports the Northern Cluster team (as appropriate) for 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, 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 (e.g., Documentum, Aris, Connect etc.) to track current product information
  • Supports the Northern Cluster 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 3 : 5 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

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