Job Title: Regulatory Affairs Associate (Labeling)
Location: Newark, CA
Position Overview: We are seeking a talented Regulatory Affairs Associate with expertise in labeling to join our Regulatory Affairs team. The successful candidate will play a crucial role in ensuring compliance with regulatory standards and guidelines related to product labeling. This position offers an exciting opportunity to contribute to the development and commercialization of life-changing therapies in a dynamic and collaborative environment.
Responsibilities:
- Develop and maintain regulatory documentation for product labeling, including package inserts, patient leaflets, and labeling supplements.
- Ensure compliance with regulatory requirements, including FDA regulations and international labeling guidelines.
- Collaborate with cross-functional teams to review and approve labeling content for new product launches and product updates.
- Manage labeling-related submissions to regulatory agencies and respond to inquiries as needed.
- Stay informed about changes in regulatory requirements and industry best practices related to labeling.
If this sounds like you or someone you know, let me know. My client is looking to move quickly with this position.
Please email me at Colby.Hurst@epmscientific.com
