Job highlights

- Bachelor's or Master's in Life Sciences or related fields with knowledge of FDA, EMA, CDSCO, ICH guidelines
- Support regulatory submissions, coordinate with QA/QC and clinical teams, ensure GMP/GCP/GLP compliance, manage document control, and assist in audits

Job Profile A Regulatory Affairs Associate is responsible for supporting regulatory submissions, documentation, and compliance activities to ensure that pharmaceutical products, medical devices, and clinical research activities meet applicable regulatory requirements. The role involves preparing, reviewing, compiling, and maintaining regulatory documents in accordance with national and international regulatory guidelines. Role & responsibilities

Assist in regulatory intelligence activities by researching updated guidelines, policies, and regulatory requirements.

Coordinate with Quality Assurance (QA), Quality Control (QC), Clinical Research, Manufacturing, and Pharmacovigilance teams.

Ensure adherence to Good Manufacturing Practices (GMP),



Valuable Clinical Practices (GCP), and Good Laboratory Practices (GLP).

Assist in document control, version management, archival, and submission tracking.

Support regulatory audits, inspections, compliance assessments, and corrective and preventive actions (CAPA).

Review product labeling, packaging information, and regulatory safety documentation.

Ensure accuracy, completeness, and timely submission of regulatory documents.

Preferred candidate profile

Bachelor's or Master's degree in Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmacy, or Clinical Research.

Freshers and candidates with 02 years of experience in Regulatory Affairs, Clinical Research, or Pharmaceutical Documentation are preferred.

Basic understanding of national and international regulatory guidelines, including FDA, EMA, CDSCO, ICH, and WHO.

📌 Regulatory Affairs Associate (Hyderabad)
🏢 Airvin Skills
📍 Hyderabad