- 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.
- Strong 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.