We are looking for a highly skilled and experienced professional to join our team as a Drug Regulatory Affairs specialist in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs and a passion for ensuring compliance with regulatory requirements.

Roles and Responsibility

- Develop and implement regulatory strategies to ensure compliance with pharmaceutical regulations.
- Prepare, review, and submit regulatory documents such as clinical trial applications, marketing authorizations, and periodic safety update reports.
- Collaborate with cross-functional teams including R&D;, Quality Assurance, and Manufacturing to ensure alignment with regulatory requirements.
- Monitor and analyze changes in regulatory environments that could impact product development or commercialization.




- Provide training and guidance to internal stakeholders on regulatory requirements and procedures.
- Maintain accurate records of regulatory interactions, submissions, and correspondence.

Job Requirements

- Bachelor's degree in Pharmacy (B.Pharm) or Master's degree in Science (M.Sc.).
- Minimum 2 years of experience in drug regulatory affairs or a related field.
- Solid knowledge of pharmaceutical regulations including FDA, EMA, and ICH guidelines.
- Excellent communication, writing, and project management skills.
- Ability to work independently and collaboratively as part of a team.
- Strong analytical and problem-solving skills with attention to detail.

📌 Drug Regulatory Affairs Professional (Delhi)
🏢 Naukri Healthcare Jobs
📍 Delhi