Roles and Responsibility
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 quick-paced setting 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.