Job Description:

Purpose:
The position is for working on product registrations in Brazil, Mexico and LATAM including compiling dossiers, answering queries from regulatory agencies, liaising with the cross-functional teams to obtain needful documents for product registration and co-ordinate on the requirements from the regional partners and regulatory agents. Managing the work deliverables by ensuring balanced and timely co-ordination with BD, regulatory agents and cross-functional stakeholders.

Position / Job Title:
Manager/Senior Manager

Department:
Regulatory Affairs

Reporting To:
General Manager, Regulatory Affairs

Location:
Thane

Years of Experience:
10-12 years

Dosage Form:
Any dosage form

Job Responsibilities / Deliverables:

Provide regulatory strategy and guidance to cross-functional teams by conducting gap assessments, identifying regulatory requirements, and ensuring clarity on documentation needs for successful product registrations across Brazil, Mexico, and other LATAM markets.
Lead the preparation, compilation, review,



and submission of regulatory dossiers for recent product registrations, renewals, variations, and other lifecycle management activities in accordance with country-specific regulatory requirements and timelines.
Manage end-to-end regulatory submission projects by ensuring effective coordination among Business Development, regulatory agents, manufacturing sites, and internal cross-functional stakeholders to achieve planned filing and approval objectives.
Collaborate with Quality Assurance, Research & Development, Manufacturing, Clinical and other departments to obtain, review, and verify technical, quality, and administrative documentation required for regulatory submissions.
Serve as the primary liaison with local regulatory agents, distributors, and in-country representatives across Brazil, Mexico, and LATAM countries, ensuring timely communication and fulfillment of regulatory requirements for product registrations and approvals.
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📌 Senior Manager (Thane)
🏢 Rubicon Research
📍 Thane