Director, Regulatory Affairs
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, include 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), 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
KNOWLEDGE AND SKILL REQUIREMENTS:
• At least Bachelor's degree in a scientific discipline Preferred Masters or Ph.D.
• 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.
• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law