Director, Regulatory Affairs - South San Francisco, CA | Biospace
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Director, Regulatory Affairs

Rigel Pharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
8/14/2017
Position Type:
Full time
Job Code:
R17-016-18-01
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Regulatory Affairs,

Job Description

ABOUT RIGEL:
Rigel is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. Our business strategy is to transition to a commercial-stage company with our Phase 3 results from fostamatinib in immune thrombocytopenic purpura (ITP); Rigel has submitted an NDA. We continue to build an extensive portfolio of products in immunology and oncology, monetizing select assets through attractive partnerships. The Director of Regulatory Affairs will be actively working cross-functionally and lead Regulatory Affairs efforts across Rigel’s various programs.


POSITION SUMMARY:
Reporting to the Sr. Vice President of Regulatory Affairs, the successful candidate will provide expertise in translating regulatory requirements into practical, workable plans for development stage drugs. Candidate will have primary responsibility for activities pertaining to submissions to, and communications with, the FDA and other Health Authorities and manage the activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.


ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•   Develop regulatory strategies for assigned programs in collaboration with Regulatory senior management and through analysis of guidance and assessment of drug pipeline
•   ?Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, including preparation and maintenance of IND or CTA filings
•   Oversee development of all regulatory filings in support of program???
•   ?In collaboration with team, perform/manage critical analyses of data (clinical, preclinical and manufacturing) and independently develop interpretations and conclusions
•   Review of clinical protocols, clinical study reports, Chemistry, Manufacturing and Controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements???
•   ?Oversee and participate in submission-related activities for CTAs, INDs, BLAs
•   ?Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages???
•   ?Responsible for communications with the FDA and/or other Health Authorities???
•   ?Oversee and ensure compliance with regulatory procedures and work practices
•   ?Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks???
•   ?Train and mentor regulatory personnel on strategic matters, related to company and external information. Maintains a positive team spirit and leads by ethical principles

Requirements

KNOWLEDGE AND SKILL REQUIREMENTS:
•   At least a Bachelor's degree in a scientific discipline; Master’s degree or Ph.D. preferred
•   Minimum of 10 years of experience in Regulatory Affairs with at least five years of management and demonstrated leadership experience
•   Strategic thinker, planner, and implementer. Excellent organizational skills
•   Experience with pharmaceutical, non-clinical, and clinical development
•   Proven ability to plan and execute complex projects, proven record of delivering results within business- defined timeframes
•   Experience leading and coaching staff
•   Expert knowledge of FDA and foreign regulations and guidelines
•   Excellent written and verbal communication skills
•   Ability to make sound decisions in complex situations???
•   Demonstrated experience in the preparation and submission of INDs, BLAs, NDAs
•   Knowledge of GMPs, GLPs, GCPs
•   Proficiency in MS-word, excel, PowerPoint, adobe











Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity.
All individuals are encouraged to apply.