27 days old

Regulatory Program Director, Pharma Technical Regulatory

Roche
South San Francisco, CA

Location:  Positions can be located in South San Francisco, Vacaville or Oceanside CA as well as Hillsboro, OR.

We are actively seeking talent for our Pharma Technical Regulatory, CMC, Biologics Development Group & Biologics Marketed Products Group. In the position of Regulatory Program Director in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the productâs lifecycle and business needs. 

  • This role within Pharma Technical Regulatory is focused on the development of CMC regulatory strategies supporting biologic products.
  • Demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork, and communication is a requirement for this role. 
  • You will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives.
  • You will be responsible for timely compilation of all necessary documentation for regulatory submissions to support technical content of regulatory submissions. 
  • You will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics. With a focus on biologics products, you will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. 
  • You will support departmental business processes to document and improve best practices and work efficiencies.
  • The Regulatory Program Director must maintain a high level of professionalism, efficiency, and follow-through as the primary regulatory liaison for the assigned product. 

Qualifications:

  • The candidate must possess a Bachelorâs degree in sciences with a minimum of 10-12 years industry experience in regulatory, manufacturing, or quality related field in the pharmaceutical/biotechnology Industry. 
  • Previous direct experience in regulatory affairs CMC, including having led major submission(s), is required. 
  • Advanced knowledge of global regulations and guidelines of major regions (e.g., FDA, ICH, EMA, WHO). 
  • Effective problem solving skills and excellent interpersonal/collaboration skills and the ability to prioritize multiple tasks. 
  • Strong leadership and excellent collaboration and communication skills (verbal and written). 
  • Ability to lead a technical regulatory sub-team for one or more products. 
  • Demonstrated ability to coordinate and work effectively with cross-functional teams and drive results. 
Posted: 2019-01-25 Expires: 2019-02-24

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Regulatory Program Director, Pharma Technical Regulatory

Roche
South San Francisco, CA

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