- Develop and implement regulatory strategies to achieve business objectives.
- Prepare and review regulatory documents such as clinical trial applications and marketing authorizations.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Conduct thorough reviews of regulatory submissions to identify areas for improvement.
- Provide training and guidance on regulatory affairs matters to internal stakeholders.
- Stay up-to-date with changing regulatory requirements and industry trends.
Job Requirements
- Robust knowledge of regulatory affairs principles and practices.
- Excellent analytical and problem-solving skills.
- Ability to work effectively in a fast-paced environment and meet deadlines.
- Robust communication and interpersonal skills.
- Experience with regulatory software and systems is an advantage.
- Bachelor's degree in Life Sciences or a related field.