Regulatory Affairs Specialist
Remote Remote, CA 00000 US
Job Description
How you will make an impact
As a Regulatory Affairs Specialist, you will provide support in the development and implementation of global regulatory CMC strategies for our Partners marketed and development products. You will support regulatory activities for internal and external programs and work closely with cross-functional subject matter authorities to ensure an effective partnership and execution of regulatory requirements and the timely submission and approval of global regulatory filings.
In this role, you’ll have the opportunity to: • Review regulatory submission documents and support regulatory filings
• Interpret regulations and provide well-reasoned regulatory guidance to cross-functional project teams
• Support and lead in the preparation of health authority meeting materials and lead responses to requests for information
• Research, prepare and present on global regulatory topics to internal and external collaborators
• Assure compliance with all applicable regulations including regulatory change management To succeed in this role, you’ll need: • Minimum of BS degree in science with minimum 3 years of experience in Regulatory Affairs CMC in the biotech/pharmaceuticals industry (an equivalent combination of education/experience will be considered)
• Proven experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations
• Proven experience and success in applying regulatory knowledge to various situations
• Excellent writing, communication, and interpretive skills
• Experience filing and knowledge of European/global submissions a plus
• Experience in regulatory management of commercial products a plus
 Pay Rate Range: $60-80/hr depending on experienceÂ
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