Senior Officer

Purpose

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

Position / Job Title

Sr.Officer / Executive

Department

Regulatory Affairs – Regulated Markets (UK, EU)

Reporting To

Manager/Sr. Manager, Regulatory Affairs

Location:

Thane

Years Of Experience

3 to 6 years

Dosage Form

Any dosage form

Key Responsibilities

• Prepare, compile, review, and submit regulatory dossiers for product registrations in regulated markets, through National, DCP, MRP and RUP procedure in United Kingdom and the European Union, in compliance with applicable regional regulations and regulatory authority requirements.
• Execute assigned product registration activities, including dossier preparation, application submission, tracking regulatory milestones, and coordinating timely responses to regulatory authority queries, deficiency letters, and requests for additional information.
• Prepare and manage post-approval regulatory submissions, including variations, renewals, sunset clause, annual reports, and maintenance of existing product registrations to ensure ongoing regulatory compliance.
• Coordinate with cross functional team like Research & Development, Quality Assurance, Manufacturing, Clinical, Supply Chain teams to obtain, review, and maintain technical, quality, and administrative documentation required for regulatory submissions.
• Monitor submission timelines and ensure timely completion of assigned regulatory deliverables in line with business objectives.
• Maintain regulatory databases, submission trackers, document management systems, and product registration records to ensure data accuracy, completeness, and inspection readiness.
• Monitor changes in applicable regulatory requirements, guidance documents, for assigned markets, and communicate relevant updates to the Manager and internal stakeholders.
• Ensure compliance with internal quality systems, regulatory procedures, and applicable international regulatory requirements throughout the product lifecycle.
• Support regulatory inspections, audits, and internal compliance activities by maintaining complete and accurate regulatory documentation.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance regulatory processes, documentation practices, and submission efficiency.
  
  

• Must have 3-6 years of Regulatory experience especially UK, EU markets.
• Should have experience in dossier preparation, submission, query responses and registration in regulated countries.
• Should be an M.Pharm/M.Sc
• Good communication and planning skills.
  
  

• May need to work in different shifts
• May need to travel to manufacturing plants when required.