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Job Details

Senior Manager, Regulatory Affairs – CMC

Company: RBW Consulting
Location: San Rafael, California
Reference: RAA-SMRACMC-SACA
Closing Date: 11 Jan 18
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Senior Manager, Regulatory Affairs – CMC

California, USA

Description 
As a Senior Manager in Regulatory Affairs, CMC, you’ll be responsible for: 

  • Proactively managing Chemistry, Manufacturing & Controls (CMC) aspects of one or more global clinical programs including overseeing preparation and submission of global CMC submissions, including clinical trial and marketing applications; ensure that CMC content is complete and meets all relevant requirements.
  • Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes.
  • Researching and interpreting global CMC regulations and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization.
  • Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
  • Managing interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. 
  • Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

EXPERIENCE 

Required Skills: 
 

  • At least 8years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle).
  • Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe.
  • Experience in assessing post-marketing changes.
  • Proven ability to lead cross functional CMC teams on projects and sub-teams.
  • Thorough understanding of relevant CMC drug development regulations and guidelines.
  • Outstanding interpersonal and communication (written and verbal) skills is required.
  • Able to work in a matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO’s in the international markets.
  • Proficiency with standard software programs (e.g., Word).  
     

Desired Skills: 

  • Project management skills are a plus.
  • Experience with coaching, training and mentoring team members.
  • Proven ability to successfully interact with Regulatory Authorities.
  • Strong background in chemistry, molecular biology, or similar is desirable  

EDUCATION 

  • BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.  Ph.D. is preferred.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Senior Manager, Regulatory Affairs – CMC

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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