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Regulatory Affairs Manager

Company: CyberCoders
Location: Richmond
Posted on: July 28, 2020

Job Description:

Regulatory Affairs Manager
If you are a Regulatory Affairs Manager with experience, please read on!Title: Regulatory ManagerLocation: Richmond, CAWe are a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. We aim to provide a complete range of services from early custom development to clinical manufacturing to our global clients.


What You Will Be Doing
- Lead the preparation of regulatory submissions including routine IND submissions, clinical trial applications (CTAs), supplemental marketing applications, and routine reports- Manage the development and review of responses to health authority queries in a timely manner- Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy- Develop and implement regulatory strategies to meet project deliverables and mitigate potential regulatory risks- Research relevant regulatory precedents to bring innovative approaches to the crossfunctional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the commercial program
What You Need for this Position
- Professional Regulatory Affairs Experience within a Pharmaceutical/Biotech environment - Compilation and Submission experience- IND Dossier Experience
What's In It for You
- Competitive base salary and overall compensation package- Full benefits: Medical, Dental, Vision- 401 (K) with generous company match- Generous Paid time off (PTO)- Vacation, sick, and paid holidays- Life Insurance coverage

So, if you are a Regulatory Affairs Manager with experience...1. Apply directly to this job opening here!OR2. E-mail directly for more information to rex.redjai@CyberCoders.com
- Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Keywords: CyberCoders, Richmond , Regulatory Affairs Manager, Executive , Richmond, California

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