We are looking for a highly skilled and experienced professional to join our team as a Regulatory Affairs specialist in the EU Submissions department. The ideal candidate will have a strong background in regulatory affairs, particularly in the pharmaceutical industry.

Roles and Responsibility
- Prepare and submit regulatory documents to European authorities, including marketing authorizations and periodic safety update reports.
- Develop and implement regulatory strategies to ensure compliance with EU regulations.
- Collaborate with cross-functional teams, including legal, quality assurance, and product development.
- Conduct thorough reviews of regulatory submissions to ensure accuracy and completeness.




- Maintain up-to-date knowledge of changing regulatory requirements and guidelines.
- Provide training and guidance to internal stakeholders on regulatory affairs matters.

Job Requirements
- Strong knowledge of EU regulatory requirements, including MDR 2017/745 and GMP.
- Experience in preparing and submitting regulatory documents to European authorities.
- Excellent communication and project management skills.
- Ability to work independently and collaboratively as part of a team.
- Robust analytical and problem-solving skills.
- Familiarity with regulatory software and systems is an advantage.

📌 Regulatory Affairs Professional (Mumbai)
🏢 Naukri Healthcare Jobs
📍 Mumbai