Sr. Manger Regulatory Affairs

San Rafael, CA 94901

Posted: 03/15/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 5794

Summary
 

The Senior Regulatory Affairs Manager is responsible for clinical and nonclinical aspects of domestic and international regulatory affairs to support global commercialization efforts and life-cycle management for multiple commercial programs. Exciting opportunity to join the Regulatory Clinical/Nonclinical group and gain global marketing application experience for multiple orphan products! Possibility for this position to expand scope into future preclinical/clinical development programs.
Responsibilities

• Provide clinical/nonclinical regulatory strategy and content to support preparation, submission, management and maintenance of domestic and international regulatory submissions including: INDs/CTAs and amendments; global Marketing Applications (MAs) and amendments/supplements; Orphan drug applications; Expedited review requests; Post-marketing requirements/commitments and Annual Reports.

• Provide strategic regulatory insight on clinical/nonclinical aspects of programs and ensure implementation of regulatory concepts within the global regulatory team and cross-functional project teams

• Assist in coordination and preparation for global health authority meetings and associated briefing documents/presentations

• Ensure compliance with existing product licenses (ie, annual reports - IND, PMR, BLA/NDA, DSUR/PBRER, RMP) fulfillment of post-marketing requirements and commitments; and maintain master CTD content

• Participate/facilitate relevant functional area and project team meetings

• Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies

• Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics

• Exercise discretion and independent judgment in the performance of the above duties


 

 
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