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 environments 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.
- Strong analytical and problem-solving skills.