Roles and Responsibility
Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.
Prepare and review regulatory documents such as clinical trial applications, marketing authorizations, and periodic safety update reports.
Collaborate with cross-functional teams including legal, quality assurance, and clinical operations to ensure alignment with regulatory requirements.
Monitor and analyze changes in regulatory settings that could impact product development or commercialization.
Provide training and guidance to internal stakeholders on regulatory affairs matters.
Ensure timely submission of regulatory documents to meet business objectives.

Job Requirements
Bachelor's degree in Life Sciences or a related field.
Proven experience in regulatory affairs within the pharmaceutical industry.
Solid knowledge of FDA regulations, ICH guidelines, and other applicable regulations.
Excellent written and verbal communication skills.
Ability to work independently and collaboratively as part of a team.
Robust analytical and problem-solving skills.

📌 Regulatory Affairs Specialist Ahmedabad (India)
🏢 Naukri Healthcare Jobs
📍 India