Offer summary
Qualifications:
Bachelor's degree in scientific or health sciences, Minimum of 5 years in regulatory affairs or drug development, Knowledge of local/regional regulatory procedures, Demonstrated ability to manage risk in a regulated environment, Strong written, spoken and presentation skills.
Key responsabilities:
- Establish local regulatory strategy and plan for products
- Provide regional regulatory expertise for submissions and approvals
- Lead interactions with regional regulators and support the labeling strategy
- Ensure compliance with regulations and internal quality systems
- Mentor GRA personnel and promote continuous improvement projects