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 including legal, quality assurance, and clinical operations.
- Conduct thorough reviews of regulatory submissions to ensure compliance with relevant laws and regulations.
- Provide guidance on regulatory requirements to internal stakeholders.
- Stay up-to-date with changing regulatory environments and develop contingency plans.
Job Requirements
- Bachelor's degree in Life Sciences or a related field.
- Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Strong knowledge of FDA regulations, GCP guidelines, and ICH guidelines.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively in a fast-paced setting and meet deadlines.
- Strong attention to detail and ability to manage multiple tasks simultaneously.