We are looking for a highly skilled and experienced Regulatory Submission Specialist to join our team at a reputed pharmaceutical company in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs and submission preparation.

Roles and Responsibility

- Prepare and review regulatory submissions, including clinical trial applications, marketing authorizations, and periodic safety update reports.
- Ensure compliance with relevant regulations, guidelines, and standards.
- Collaborate with cross-functional teams, including R&D;, quality assurance, and legal affairs.
- Develop and maintain relationships with regulatory authorities and stakeholders.
- Stay updated with changing regulatory requirements and implement necessary changes.




- Provide training and guidance to junior staff on regulatory affairs and submission preparation.

Job Requirements

- Bachelor's degree in Pharmacy or related field; advanced degree preferred.
- Minimum 5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Solid knowledge of regulatory requirements, guidelines, and standards.
- Excellent communication, writing, and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficient in regulatory software and systems.

📌 Regulatory Submission Specialist (Mumbai)
🏢 Naukri Healthcare Jobs
📍 Mumbai