Senior Manager

Purpose: Manage product registrations in regulated markets of UK, EU, Canada and Australia including preparing dossiers, submitting applications for product registrations, addressing query responses to obtain product approvals, submitting necessary post approval variations and meeting any annual requirements. Liaise with the cross-functional teams and manufacturing plant to obtain needful documents for product filings. Interacting with the regulatory bodies as required on administrative and technical matters. Manage a team of professionals to deliver the planned filings and necessary approvals.

Position / Job Title: Manager/Senior Manager

Department: Regulatory Affairs- Regulated Markets (UK, EU, CA and AU)

Reporting To: General Manager, Regulatory Affairs

Location: Thane

Years of Experience: 10-15 years

Dosage Form: Any dosage form

Job Responsibilities / Deliverables

Provide strategic regulatory guidance to cross-functional teams by conducting comprehensive gap assessments, identifying regulatory risks, and defining documentation requirements to support timely product registrations and lifecycle management activities.

Lead regulatory submissions and product registration activities across highly regulated markets including the United Kingdom, European Union, Canada, and Australia. Prepare, compile, review, and submit high-quality registration dossiers in compliance with applicable regional regulations and regulatory authority requirements.

Manage end-to-end registration processes, including regulatory strategy development, dossier preparation, application submission, tracking approvals, and coordinating responses to deficiency letters, technical queries, and authority requests to ensure successful and timely product approvals.

Oversee post-approval regulatory activities, including variations, amendments, renewals, annual reports, notifications, and maintenance of existing licenses and registrations, ensuring continued regulatory compliance throughout the product lifecycle.

Collaborate closely with Research & Development, Quality Assurance, Manufacturing, Clinical, and other internal stakeholders to obtain, review, and maintain required technical, quality, and administrative documentation for regulatory submissions.

Interact with the regulatory bodies as required on administrative and technical matters.

Monitor and interpret evolving regulatory requirements, guidelines, and industry trends within assigned markets, assessing their impact on existing products and future business strategies.

Maintain regulatory databases, submission trackers, and documentation systems to ensure accurate records, and regulatory intelligence.

Lead, mentor, and manage a team of regulatory professionals, ensuring effective workload planning, capability development, performance management, and achievement of regulatory filing and approval targets.

Drive operational excellence within the regulatory function by establishing best practices, improving submission processes, and ensuring timely delivery of planned regulatory milestones and approvals.

Qualifications & Pre-Requisites

Must have 10-15 years of Regulatory experience especially UK, EU, CA and AU markets.

Should have experience in dossier preparation, submission, query responses and registration in regulated countries.

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

Should be an M.Pharm/M.Sc

Good communication and planning skills.

Additional Notes

Will need to work in different shifts.

May need to travel to manufacturing plants when required.