Regulatory Affairs Specialist

We are looking for an experienced Regulatory Affairs Specialist to join our team at Roche and help us develop strategies and solutions to ensure product compliance with global regulatory standards. This position requires an individual who is highly organized, motivated, and has in-depth knowledge of regulatory processes.As a Regulatory Affairs Specialist, you will be responsible for managing the regulatory aspects of product development and commercialization, ensuring that we are meeting all regulatory requirements. You will collaborate with internal teams, as well as external partners and regulatory authorities, to ensure that our products meet all applicable requirements.The ideal candidate for this role will have a degree in a life sciences field such as biology, chemistry, or pharmacology and at least 5 years of experience in regulatory affairs. You will also have excellent communication skills, as you will be coordinating with a variety of teams. If you are looking for an exciting opportunity to make a difference at Roche, we encourage you to apply!

Responsibilities:

1. Develop strategies and solutions to ensure product compliance with global regulatory standards
2. Manage the regulatory aspects of product development and commercialization
3. Ensure that all products meet applicable regulatory requirements
4. Collaborate with internal teams, external partners, and regulatory authorities
5. Maintain up-to-date knowledge of all relevant regulations and standards
6. Coordinate with a variety of teams to ensure regulatory compliance
7. Prepare and submit regulatory documentation to support product development and commercialization
8. Monitor regulatory changes and provide guidance to internal teams on how to adjust accordingly
9. Respond to inquiries from regulatory authorities
10. Prepare reports for management on regulatory activities

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in South San Francisco, CA, USA is $50,000 to $80,000 per year. This range is based on salaries reported by employers to JobzMall.

Roche Holding AG operates as a research healthcare company. It operates through the diagnostics and pharmaceuticals segments. The pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases and neuroscience. The diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process.