This role is responsible for preparing, reviewing, and maintaining regulatory documentation related to regulatory affairs, ensuring compliance with regional and global regulatory requirements. The specialist collaborates with clinical operations, quality, and supply chain teams to support regulatory submissions and approvals needed for clinical studies and associated medical devices, equipment, and supplies. Daily activities include tracking regulatory timelines, managing communication with regulatory authorities or local representatives, and supporting audits and inspections.

The role also involves monitoring regulatory changes, advising project teams on implications for clinical supply and trial conduct, and contributing to process improvements and best practices in regulatory affairs.

Qualifications
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Biochemistry, Microbiology, Clinical Research, Healthcare, Biomedical Sciences, or a related field.
1–5 years of experience in Regulatory Affairs, Regulatory Compliance, Clinical Research, Clinical Operations, Pharmaceutical, Medical Device, Biotechnology, CRO, Healthcare,



or related industries.
Experience in Clinical Regulatory Affairs, regulatory documentation, regulatory submissions, product registration, compliance, or regulatory operations is preferred.
Knowledge of country-specific regulatory requirements, international regulations, and regulatory guidelines.
Exposure to clinical trials, clinical supplies, medical devices, pharmaceutical products, or healthcare products is an advantage.
Knowledge of import/export regulations, permits, licenses, registrations, approvals, and IOR/EOR (Importer/Exporter of Record) activities is preferred.
Ability to monitor regulatory changes, assess regulatory requirements, identify compliance risks, and support mitigation activities.
Robust skills in regulatory documentation, document review, record keeping, and maintaining traceability.
Ability to coordinate with regulatory authorities, CROs, vendors, clients, internal teams, and international stakeholders.
Robust written and verbal communication, coordination, organizational, and stakeholder-management skills.

📌 Regulatory Affairs Specialist – Clinical New Delhi
🏢 Intrinseque Health
📍 New Delhi