Position: Regulatory Affairs Associate
Department: Scientific and Regulatory Affairs
Location: Bengaluru, Karnataka (On- Site)
Reporting To: Manager, Scientific and Regulatory Affairs
Role Overview:
Regulatory Affairs Associate with experience to develop, review, and manage high-quality regulatory documentation in compliance with applicable guidelines and standards.
Key Responsibilities:
· Prepare, review, and coordinate regulatory submissions, including applications for approvals, amendments, and clarifications.
· Track and follow up on submission status and ensure timely responses to queries raised by regulatory agencies.
· Prepare and submit regulatory amendments, notifications, responses to deficiency letters, and supporting documentation within prescribed timelines.
· Review regulatory dossiers and supporting documents for accuracy, consistency, and compliance with current regulatory requirements.
· Facilitate and coordinate meetings, presentations, and discussions with regulatory officials to support ongoing and upcoming projects.
· Maintain updated knowledge of Indian regulatory frameworks, including CDSCO MDR 2017, NDCT rules 2019, Drugs and Cosmetics Act and Rules, ICMR guidelines, and other applicable standards.
· Draft and review regulatory correspondence, meeting notes, and briefing documents.
· Contribute to SOP development, revision, and implementation.
· Develop, maintain, and update related templates, forms, checklists, logs, and standard document formats.
· Ensure controlled documents are current, approved, and available to project teams.
· Support implementation and continuous improvement of documentation processes.
· Maintain document repositories.
· Assist in audit and inspection readiness activities.
· Maintain meeting minutes, project trackers for all regulatory deliverables.
· Track document progress, review status, comments reconciliation, and approval workflows.
· Track key milestones, deliverables, and project timelines.
· Identify potential delays and proactively escalate risks to project stakeholders.
· Provide regular status updates and project reports.
· Schedule review meetings, collect feedback, and facilitate resolution of review comments.
· Support vendor and consultant management activities related to regulatory projects.
· Ensure effective communication among cross-functional teams.
Qualifications & Skills:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related field.
- 2-5 years of experience in regulatory affairs within pharmaceutical, medical device, CRO, or healthcare industries.
- Working knowledge of applicable regulatory requirements and guidelines, including CDSCO, ICH-GCP, NDCT Rules, Medical Device Rules, and global regulatory frameworks where applicable.
- Hands-on experience with regulatory submissions, amendments, notifications, responses to regulatory queries, and maintenance of regulatory records throughout the study lifecycle.
- Strong written and verbal communication skills with excellent attention to detail and document quality.
- Good command over English language, communication and interpersonal skills for effective interaction with the regulatory personnel and stakeholders.
- Experience in preparation and maintenance of the study documentation and regulatory submission forms.
- Strong analytical to interpret clinical and regulatory data and develop accurate, compliant documentation and submission dossiers.
- Detail-oriented with strong organizational and problem-solving skills.
- Ability to manage multiple tasks including multiple documents preparation/ review, projects, and timelines efficiently in a fast-paced research environment.
About Trial Guna Private Limited:
Trial Guna Private Limited (TGPL) is a Clinical Research Organization (CRO) committed to advancing innovative research solutions. We specialize in conducting high-quality, ethically compliant clinical trials that contribute to the development of effective medical treatments. At TGPL, we foster a dynamic and collaborative work environment that encourages professional growth and excellence.
We look forward to welcoming a dedicated professional to our team who shares our passion for clinical research excellence.
Pay: ₹450,000.00 - ₹500,000.00 per year
Benefits:
- Cell phone reimbursement
- Flexible schedule
- Paid time off
- Provident Fund
Work Location: In person
