Senior Lead For Regulatory Affairs / Corporate Quality (Full Time)
Location: Redwood City, CA
Rezolute, Inc. is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. The company’s pipeline includes four programs comprised of two clinical stage compounds and one late pre-clinical stage platform. Rezolute recently announced a $25M raise with a $45M potential and has opened an office in Redwood City, CA. We are now seeking highly qualified and dynamic individuals to join and help grow our emerging biopharma company. More information can be found at www.rezolutebio.com
The Senior Regulatory Affairs and Corporate Quality professional will ensure conformance with established global regulations in the conduct of clinical trials and conduct regulatory submissions in support of development and marketing of global products. They will manage and, as needed, build a premier regulatory group that provides strategic leadership for regulatory strategy, regulatory operations, and agency interactions and submissions, both domestically and globally. As the Corporate Head of Quality, they will lead GxP Quality oversight, ensuring patient protections, GMP product release, and implementation of quality assurance, controls, and compliance systems per GxP, ICH, and corporate standards and operating policies.
- Work cross-functionally to develop and implement US and Global regulatory strategy
- Provide regulatory guidance that expedites the review process for drugs with an orphan designation
- Represent Regulatory function and present and defend regulatory plans to Senior Management
- Convert strategy to regulatory execution. Provide leadership of internal resources and external partners to ensure successful regulatory execution
- Provide leadership of global regulatory submissions including but not limited to INDs, NDAs/BLAs, IMPDs/MAAs, supplemental applications, meeting packages, annual reports, CTAs, IBs, safety reports, breakthrough/orphan filings, etc.
- Lead and/or participate in regulatory interactions with and presentations to US FDA and other regulatory agencies
- Foster strong relationships and promote a positive company image with FDA and international regulatory authorities
- Provide overall leadership and accountability for Quality at Rezolute; act as final authority on the release of product for human consumption.
- Demonstrate application of phase appropriate GMPs as applied to Rezolute cGMP development, manufacturing, and testing.
- Responsible for Quality Assurance, Quality Control, and GxP Compliance functions in support of formulation, product development and via an externalized global CMO / CRO / CLO network.
- Proactively identify program risks and mitigation strategies, from a Regulatory and Quality perspective
- Negotiate, interact with, and oversee the activities of contract organization(s) in the preparation of regulatory documents and submissions
- Provide regulatory review and approval of external communications in support of clinical trials and marketing of approved products
- Interpret, implement, oversee, train, and provide key input to staff on regulatory guidelines, GxP and ICH regulations, and corporate standards and operating procedures, and proactively ensure compliance with all relevant regulations and guidelines
- Primary responsibility for audit readiness and responses during inspections
- Represent and Support Regulatory and Quality functions to Regulatory agencies and in company’s corporate and business development activities
Job Requirements and Candidate Qualifications:
- Bachelor’s Degree in a scientific discipline required; RPh, PharmD, PhD or MD degree preferred
- The ideal candidate will possess at least 12 years of experience in Regulatory Affairs within the pharmaceutical industry including at least 8 years of experience in management and/or senior leadership roles; prior experience in Quality-related roles preferred; demonstrated understanding of late phase Quality requirements.
- Experience in small and/or large molecules for orphan and/or ultra-orphan diseases, including primary pediatric indications, is advantageous
- Demonstrated experience and abilities that are commensurate with being able to successfully perform the job responsibilities
- Broad working knowledge of GMPs, GLPs, and GCPs
- Building and running Regulatory Affairs and Quality functions within an emerging biopharma company is also an advantage, including an understanding of how to leverage the resources of an emerging biopharma company to successfully manage multiple priorities across a diverse therapeutic pipeline.
- Demonstrated ability to thrive in and positively contribute to a dynamic, lean, flat, and cross-functionally integrated emerging biopharma company in both a strategic and hands-on manner
- Results driven and team-oriented, with the ability to influence outcomes
- Excellent organizational, written, and verbal communications
- Possesses project, time management, and organization skills and the attention to detail required to drive multiple ongoing projects simultaneously
- Entrepreneurial, innovative, analytical, and solution-minded
- Proficiency in MS-Word, Excel, PowerPoint, and Adobe Acrobat
- Willingness to travel up to 15-20% (domestic and international)
Interested and qualified candidates should send resume to email@example.com, to the attention of Brian Roberts