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Regulatory Affairs Executive

2 weeks ago

Mumbai, Maharashtra, India Talent Sutra Full time US$ 90,000 - US$ 1,20,000 per year

Designation:
Regulatory affairs -Executive/ Sr. Executive

Job Location:
Mumbai

Job Summary:

The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR and Annual reports etc to Regulatory authorities. Queries response compilation and submission to Regulatory bodies.

Responsibilities:

Manages all the functions of the Regulatory Department including but not limited to-*Scheduling all the activities of the department.

Job Description:

  • Dossiers compilation /Review for ROW, ZAZIBONA, Emerging market and EU (National, DCP, MRP MA) applications.
  • Responsible for the Lifecycle management of assigned Products according to EU regulations and other country regulation where the Product is registered.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new product Dossiers and CMC variations.
  • CTD, ACTD Dossier compilation according to country requirements and understanding of E2E product development and filing strategies.
  • Maintaining database of Regulatory submissions.
  • Coordination and follow up with QC, QA, F&D, ADL, Manufacturing, packing teams, finished product manufacturers, contract manufacturer for getting all necessary technical documents as per CTD requirement.
  • Prepare and review SmPC, PIL, Artwork etc.
  • Ensure adherence to deadlines and Regulatory compliance of submission to health authorities.

  • Preparation of Application to Regulatory bodies for all necessary approvals, FDA, CDSCO and international Regulatory bodies.

  • Queries response compilation and submission to Regulatory Authorities for Product registration and renewal.

  • Post approval (PAS) compliance by compilation and review of documents.
  • Coordinating the inspection of the organization facilities, contract facilities and developing procedure to ensure Regulatory compliance.
  • Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals).
  • Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines.
  • Communicate design changes to existing products and company practices where necessary.
  • Plan and develop product trials and interpret trial data.
  • Stay up to date with the latest rules and regulations.
  • Any other task assigned by Head of department.

Education, Specialized skills and Knowledge:

  • Master degree in Pharmacy in any specialization.
  • Candidates must have 5+ Years of RA experience.
  • Knowledge of ROW, Emerging market, ZAZIBONA and EU market requirements and ICH guidelines is must. Minimum 4 years experience in EU submission is required.
  • Fluent spoken and written English.
  • Task oriented with learning attitude and team work skills.