Key Responsibilities:
- Develop and implement regulatory strategies and plans for product development and submissions.
- Lead interactions with regulatory agencies, including the HSA, FDA, EMA, and other international bodies.
- Ensure compliance with regulatory requirements throughout the product lifecycle.
- Provide guidance on regulatory issues to project teams and senior management.
- Review and approve technical documentation, including clinical trial protocols, reports, and marketing materials.
- Monitor changes in regulatory environment and adjust strategies accordingly.
- Manage and mentor a team of regulatory professionals.
- Participate in due diligence for potential business partnerships or acquisitions.
Qualifications:
- Bachelor’s degree in a relevant scientific field; advanced degree preferred.
- Minimum of 10 years of experience in regulatory affairs within the pharmaceutical, biotech, or medical device industry.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of FDA, EMA, and other international regulatory guidelines.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment.
