We are looking for a highly skilled and experienced professional to join our team as the Regulatory Affairs & Pharmacovigilance expert. The ideal candidate will have a robust background in regulatory affairs and pharmacovigilance, with excellent analytical and problem-solving skills.

Roles and Responsibility
- Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.
- Conduct thorough reviews of regulatory submissions, including clinical trial applications and marketing authorizations.
- Collaborate with cross-functional teams to resolve regulatory issues and improve overall compliance.
- Provide guidance on regulatory requirements to internal stakeholders, including clinical development teams.
- Monitor and report on changes in regulatory environments that may impact business operations.




- Ensure timely submission of regulatory documents to meet business objectives.

Job Requirements
- Strong knowledge of pharmaceutical regulatory affairs, including FDA, EMA, and other global regulatory frameworks.
- Experience with pharmacovigilance, including adverse event reporting and risk assessment.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively in a fast-paced environment with multiple priorities.
- Strong attention to detail and organizational skills.
- Familiarity with regulatory software and systems, such as CTMS and Veeva.

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