Role & responsibilities:

- 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 productive 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.

Preferred candidate profile:

- Regulatory experience in Brazil, Mexico and LATAM markets at managerial position.

- Should be an M.Pharm/M.Sc

- Good communication and planning skills.

Interested candidates can share their profile on [email protected]

📌 Manager / Senior Manager Regulatory Affairs - LATAM (Brazil, Mexico) (Thane)
🏢 Rubicon Research
📍 Thane