Compliance Manager for Pharmaceutical Operations

2 weeks ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairsManager Full time ₹ 20,00,000 - ₹ 40,00,000

Regulatory Compliance Lead

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  • Job Description:

  • Ensure timely regulatory submissions and compliance with regulations for the manufacturing site.
  • Provide strategic support to business operations by ensuring regulatory compliance.
  • Maintain business continuity through proactive regulatory planning and execution.

 

Key Responsibilities:

  • Prepare and submit applications, such as additional product permissions, layout approvals, facility modification approvals, technical person approvals, test licenses, amendments in licenses, State GMP and GLP certificate applications, and post-approval changes, to State FDA.
  • Evaluate technical and scientific data for regulatory submissions.
  • Liaise with health authorities for inspections, clarifications, and approvals.

 

Product & Business Support:

  • Handle product complaints from regulatory authorities.
  • Provide regulatory support for internalization and externalization of products.

 

Documentation & Quality Oversight:

  • Maintain and update regulatory databases, trackers, licenses, and approvals.
  • Review and track regulatory impact of quality documents.

 

Benefits:

  • Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading pharmaceutical company.
  • Familiarity with regulatory platforms is desirable.

 

Education:

  • B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

 

Additional Responsibilities:

  • Complete assigned trainings on time.
  • Perform other duties as assigned by the Regulatory Affairs leadership.

 

  • Position Accountability/Scope:

  • Responsible for all regulatory activities for the manufacturing site mainly LL sites.
  • Ensures site compliance with applicable national regulations and Abbott standards.

 

Required Skills and Qualifications:

  • Managerial experience in Regulatory Affairs.
  • Pharmaceutical or life sciences background.

 

Keyword: RegulatoryAffairsManager

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