Manager/ Senior Manager RA (Europe, UK)-Rubicon Research

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 Manage product registrations in regulated markets of UK, EU, 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.

Interested candidates may apply on [email removed]

DM at [phone removed] to discuss more about the role