Regulatory Affairs Associate
Location: Fremont, CA
Our innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.
Key Responsibilities:
- Prepare and coordinate regulatory submissions, including amendments, supplements, annual reports, and safety reports.
- Develop regulatory strategies for manufacturing changes and activities.
- Manage workflows for regulatory submissions, ensuring they meet global standards.
- Participate in cross-functional team meetings and assist with licensing activities, including Establishment Registration and state licenses.
- Support reporting requirements under the CARES Act.
Qualifications:
- Bachelor’s degree in a scientific field (Chemistry or Pharmacy preferred) with 1-3 years of experience, or a Master’s degree in Regulatory Affairs with a minimum of 3 months of internship experience.
- Proficiency in MS Office and document management systems.
- Strong understanding of global regulations and cGMP requirements.
- Excellent organizational and communication skills.
If you're looking for an exciting opportunity to contribute to regulatory compliance in a dynamic environment, we encourage you to apply!
