Search Jobs: Results: Regulatory Affairs Associate Director - Biologics

Regulatory Affairs Associate Director needed to guide a transition to biologics regulations for a dynamic and rapidly growing pharmaceutical leader:

Initial Top Challenges:  
1) Lead Regulatory reporting processes including BLA submissions, license applications and CMC reporting  projects 
2) Provide regulatory advice with regard to new facilities, qualification and comparability protocols 
3) As new products are developed or added to the portfolio, determine appropriate processes, integration and regulatory strategy 
4) Help guide a regulatory and CMC transition for a combination product from one currently with CDRH as the primary review division to one with CBER as the primary reviewer 
5) Represent Regulatory in change control decisions, design reviews, material reviews, product complaint reviews and labeling
6) Generate and present education sessions to inform the organization as to the requirements for working under new regulations

Relocation: Yes 
Location:  Southern California  
Contact: Apply below and/or at www.fpccareers.com  and/or contact Ira Mann at ira@fpccareers.com

Qualifications / Experience Required:
1) 7+ years of direct regulatory affairs experience in a biologics / CBER regulated environment
2) 12+ years of overall experience
3) BS Degree in a relevant scientific (Advanced degree preferred)  
4) BLA submissions 
5) CMC expertise
6) Mentoring and teaching others with regard to CBER regulations 

Preferred Experience: 
7) Regulatory experience in Medical Device and/or Biological & Device Combination products   
8) Regulatory Strategy experience 
9) Development level as well as early to mid stage experience 
10) Submissions experience for ROW countries 

Key Words:  CBER, BLA, PMA, biologics, biological combination device, CMC, regulatory submission, regulatory strategy, comparability protocols, robustness, drug development
 

Job Details

Name:   Ira Mann   Date Posted:   03/25/2013
Office:   Atlanta   Telephone:   (770) 246-9757
Email:   iram@fpccareers.com   Fax:   (678) 735-4297
Category:   Biotechnology, Medical Device, Pharmaceutical, Regulatory Affairs
Keywords:   CBER, BLA, PMA, biologics, biological combination device, CMC, regulatory submission, regulatory strategy, comparability protocols, robustness, drug development   Region:  
State:   CA   City:  
Education:   BS   Job Number:   J00471-ATLA-16286-IM


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