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 regulatory compliance.
Monitor and analyze changes in regulatory requirements and develop plans to implement necessary changes.
Provide training and guidance to internal stakeholders on regulatory requirements and procedures.
Maintain accurate records of regulatory interactions, submissions, and correspondence.

Job Requirements
Bachelor's degree in Life Sciences or related field required; advanced degree preferred.
Minimum 5 years of experience in regulatory affairs or a related field.
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 Hyderabad
🏢 Naukri Healthcare Jobs
📍 Hyderabad