Sr Regulatory Affairs Specialist

Overview

Senior regulatory affairs specialist within India for CRG, Thermo Fisher Scientific, providing regulatory expertise and strategic guidance to clients across product development, from preclinical stages through registration.

What you'll do

• Serve as a senior specialist contact within India at CRG, providing innovative solutions and regulatory expertise.
• Interact with clients to offer strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
• Ensure compliance with regulatory bodies in the middle east.
• Provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements.
• Act as a liaison with internal and external clients in the provision and marketing of these specialized regulatory services.
• Monitor updates to Indian clinical trial regulations, CDSCO notifications, guidelines, and applicable regulatory requirements, and communicate relevant changes to the India Regulatory Affairs Manager and project teams.
• Coordinate with local regulatory consultants for Pakistan, Nepal and Sri Lanka for the review of regulatory updates, clarification of country-specific requirements, and resolution of regulatory queries.
• Maintain regulatory trackers, submission logs, approval records, and regulatory documentation to ensure timely follow-up of submissions and compliance with applicable timelines.
• Collaborate and maintain effective alignment with Clinical Operations, Pharmacovigilance (PVG)/Drug Safety, Site Activation, and other relevant cross-functional teams.
• Coordinate with the PVG/Drug Safety team to support timely regulatory submissions, notifications, and follow-up activities.
• Support preparation, maintenance, and retrieval of regulatory documentation during inspections and audits.
• Identify potential regulatory gaps, submission delays, and compliance risks, and proactively escalate concerns to the India Regulatory Affairs Manager.

What you'll need

• Familiarity with CDSCO electronic submission systems, including the SUGAM portal.
• Basic understanding of clinical trial applications, import licence requirements, regulatory amendments, and applicable reporting obligations.
• Basic understanding of clinical trial safety reporting requirements in India, including Serious Adverse Event (SAE) reporting and applicable regulatory timelines.
• Basic understanding of regulatory inspection and audit requirements.
• Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Ability to use and learn standard office equipment and technology with proficiency.
• Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Ability to work effectively with regional and global teams across different time zones, demonstrating flexibility in working hours when required.

Details

• Standard office hours (40 per week).
• Office job environment; able to work upright and stationary for typical working hours.
• May require travel.
• Flexibility in working hours when required to support critical deliverables, attend essential meetings, and address time-sensitive requests.
• Location: Remote, India.