Regulatory Affairs Specialist

The specialist will prepare, review, and maintain regulatory documentation related to clinical trials, medical devices, and associated supplies, ensuring accuracy and alignment with global and local requirements. Day-to-day responsibilities include monitoring regulatory changes, interpreting regulations across regions, and advising internal teams on compliance implications for clinical supply chain strategies. The role will involve coordinating regulatory submissions, supporting audits and inspections, and collaborating with project management and operations teams to ensure that regulatory obligations are integrated into project plans. The specialist will also help develop standard operating procedures, contribute to risk assessments, and support continuous improvement in regulatory processes
.
Qualifications
Demonstrated ability in regulatory documentation, including drafting, reviewing, and maintaining precise and audit-ready records.
Strong knowledge of regulatory requirements and regulatory compliance in clinical research, medical devices, and related supply chain activities.
Experience in regulatory affairs, including interpretation of guidelines and collaboration with cross-functional teams to implement regulatory standards.
Hands-on experience with regulatory submissions to authorities or ethics committees, preferably in multiple regions.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
Familiarity with global clinical trial regulations (e.g., ICH-GCP), quality management systems, and ISO-certified environments.
Strong analytical, organizational, and time management skills, with attention to detail and ability to manage multiple projects.
Effective written and verbal communication skills in English; ability to present regulatory information clearly to technical and non-technical stakeholders.
Comfort working in a hybrid setup, collaborating both on-site in New Delhi and remotely with global teams.
Prior experience in clinical supply chain, medical devices, or biopharmaceutical industry is an advantage.

Work arrangement
No