Job Description :
Title: Sr. Manager Regulatory Affairs
Location: San Rafael, CA

Interview: Phone and F2F – will do skype if not local

Start: 04/22/2019
End: 12/22/2019

Reason: Interim Worker (hired to cover FTE leave of absence)

Duties: 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.

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

Skills: Experience/Skills

8-12 years of industry experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry with a clinical and nonclinical emphasis Skilled at gathering regulatory information and developing product approval strategies Proven track record of managing critical projects as a part of an interdisciplinary team Proven track record of successfully interacting with regulatory health authorities Prior experience managing regulatory submissions to deadlines Thorough understanding of relevant drug development regulations and guidelines Outstanding interpersonal and communication (written and verbal) skills Effective task planning and coordination abilities Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)

Rare disease experience is desirable
Prior experience in the metabolism or endocrinology therapeutic areas is desirable