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 new 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.

Coordinate with regulatory agents and partners to understand evolving local regulations, submission requirements, and market-specific expectations, ensuring dossiers are compliant and complete prior to submission.

Review, assess, and respond to regulatory authority queries, deficiency letters, requests for additional information, and partner-related questions, driving timely resolutions to facilitate the fastest possible product approvals.

Manage post-approval regulatory activities, including variations, amendments, renewals, notifications, annual maintenance requirements, labeling updates, and other lifecycle management submissions to maintain product compliance and market authorization status.

Monitor submission timelines, approval milestones, and regulatory commitments to ensure dossiers are filed, reviewed, and approved according to agreed business schedules and launch plans.

Maintain and continuously improve regulatory document repositories, databases, trackers, and archival systems to ensure efficient document retrieval, version control, and regulatory compliance.

Lead, mentor, and develop a team of regulatory professionals by providing technical guidance, performance coaching, and regular training on regional regulatory requirements, submission processes, and best practices.

Qualifications & Pre-Requisites Regulatory experience in Brazil, Mexico and LATAM markets at managerial position.

Should be an M.Pharm/M.Sc

Valuable communication and planning skills.

Additional notes

Will need to work in different shifts.

📌 Senior Manager (Thane)
🏢 Rubicon Research
📍 Thane