Senior Regulatory Affairs Specialist

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our colleagues with the resources needed to achieve career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our PPD® part of Thermo Fisher Scientific team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our Clinical Operations professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

Serves as a senior specialist contact within India at CRG, Thermo Fisher Scientific, providing innovative solutions and regulatory expertise. Interacts with clients to offer strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization, ensuring compliance with regulatory bodies in the middle east. Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Acts as a liaison with internal and external clients in the provision and marketing of these specialized regulatory services.

Knowledge, Skills, Abilities

• Regulatory Intelligence: Ability to 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.Ability to coordinate with local regulatory consultants for countries- Pakistan, Nepal & Sri Lanka for the review of regulatory updates, clarification of country-specific requirements, and resolution of regulatory queries, ensuring timely follow-up and alignment with the Regulatory Affairs Manager and relevant project teams.
• Regulatory Submission Systems: Familiarity with CDSCO electronic submission systems, including the SUGAM portal, and basic understanding of clinical trial applications, import licence requirements, regulatory amendments, and applicable reporting obligations.
• Regulatory Tracking and Compliance: Ability to maintain regulatory trackers, submission logs, approval records, and regulatory documentation to ensure timely follow-up of submissions, regulatory commitments, and compliance with applicable timelines.
• Cross-functional Coordination and Alignment: Ability to collaborate and maintain effective alignment with Clinical Operations, Pharmacovigilance (PVG)/Drug Safety, Site Activation, and other relevant cross-functional teams to support regulatory submissions, safety reporting coordination, timely exchange of information, and compliance with applicable regulatory requirements and timelines.
• Safety Reporting Coordination: Basic understanding of clinical trial safety reporting requirements in India, including Serious Adverse Event (SAE) reporting and applicable regulatory timelines, with the ability to coordinate with the PVG/Drug Safety team to support timely regulatory submissions, notifications, and follow-up activities.
• Regulatory Inspection and Audit Readiness: Basic understanding of regulatory inspection and audit requirements, including the ability to support preparation, maintenance, and retrieval of regulatory documentation during inspections and audits.
• Regulatory Risk Identification and Escalation: Ability to identify potential regulatory gaps, submission delays, and compliance risks, and proactively escalate concerns to the India Regulatory Affairs Manager for timely resolution.
• Adaptability and Learning Agility: Willingness to continuously develop regulatory knowledge, adapt to evolving regulatory requirements, accept feedback, and demonstrate a proactive approach to learning and professional development.
• Ability to work effectively with regional and global teams across different time zones, demonstrating flexibility in working hours when required to support critical deliverables, attend essential meetings, address time-sensitive requests, and ensure timely coordination, while maintaining accountability for assigned responsibilities and agreed timelines.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!