Manager/ Senior Manager- Regulatory Affairs (EU,UK)

Rubicon Research; Thane; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Rubicon Research seeks an experienced Regulatory Affairs leader to guide cross-functional teams in EU/UK submissions and ongoing lifecycle management. The role drives strategy, dossier preparation, and timely approvals across regulated markets.

The ideal candidate will oversee end-to-end regulatory activities, coordinate with R&D, QA, and manufacturing, and mentor a team to ensure compliance and continuous improvement across product registrations.

Qualifications

• Extensive experience in EU/UK regulatory submissions and lifecycle management.
• Experience leading cross-functional regulatory teams.
• Strong knowledge of regional regulatory requirements and filing processes.

Responsibilities

• 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 i.e, UK and Europe. 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.

Skills

Regulatory affairs

Job description

Role & responsibilities

• 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 i.e, UK and Europe. 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.

Preferred candidate profile

Candidate should have hands on experience in Pre and post Approval for EU, UK market.