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 settings 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.
Solid attention to detail and organizational skills.
Familiarity with regulatory software and systems, such as CTMS and Veeva.

📌 Regulatory Affairs Professional & Pharmacovigilance Ahmedabad
🏢 Naukri Healthcare Jobs
📍 Ahmedabad