Senior Regulatory Affairs Specialist

🔥 35 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Serve as a senior specialist contact within India at CRG, Thermo Fisher Scientific • Provide innovative regulatory solutions and regulatory expertise • Interact with clients to provide strategic regulatory intelligence and guidance from preclinical development through registration and product optimization • Ensure compliance with regulatory bodies in the Middle East • Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements • Act as liaison with internal and external clients in delivering and marketing specialized regulatory services • Monitor Indian clinical trial regulations, CDSCO notifications, guidelines, and regulatory requirements • Coordinate with consultants in Pakistan, Nepal, and Sri Lanka on regulatory updates and country-specific requirements • Maintain regulatory trackers, submission logs, approval records, and regulatory documentation • Coordinate with cross-functional Clinical Operations, Pharmacovigilance/Drug Safety, and Site Activation teams • Support SAE reporting, regulatory submissions, notifications, follow-up activities, inspections, and audits • Identify and escalate regulatory gaps, delays, and compliance risks

🎯 Requirements

• Senior specialist regulatory affairs experience and expertise • Ability to monitor Indian clinical trial regulations, CDSCO notifications, guidelines, and applicable regulatory requirements • Ability to coordinate with local regulatory consultants for Pakistan, Nepal, and Sri Lanka • Familiarity with CDSCO electronic submission systems, including the SUGAM portal • Basic understanding of clinical trial applications, import licence requirements, regulatory amendments, and reporting obligations • Ability to maintain regulatory trackers, submission logs, approval records, and regulatory documentation • Ability to collaborate with Clinical Operations, Pharmacovigilance/Drug Safety, Site Activation, and other cross-functional teams • Basic understanding of clinical trial safety reporting requirements in India, including SAE reporting and applicable regulatory timelines • Basic understanding of regulatory inspection and audit requirements • Ability to identify regulatory gaps, submission delays, and compliance risks and escalate concerns • Willingness to continuously develop regulatory knowledge and adapt to evolving requirements • Ability to work effectively with regional and global teams across different time zones • Ability to communicate and understand information with diverse groups • Ability to work upright and stationary for typical working hours • Ability to use and learn standard office equipment and technology • Ability to work under pressure while prioritizing and handling multiple projects • May require travel

🏖️ Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Flexible working hours when required to support critical deliverables and meetings

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