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SVP/VVP, Regulatory Affairs & Quality Assurance
143278
Posted:
18/09/2024th
18/09/2024
- 280000 $ - 350000 $
- San Francisco, United States
- Permanent
Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer. Reporting to the CEO, the Head of Regulatory Affairs & Quality Assurance is a top executive responsible for building and overseeing quality assurance and regulatory functions for Electra Therapeutics. This person will be the primary point of contact with all global regulatory authorities. As part of the leadership team, this person is responsible for bringing global regulatory and compliance perspective to product development strategies. Further, this person is responsible for ensuring successful implementation of product development strategies to ensure compliance with global regulatory and quality expectations. This person will be responsible for building and managing a highly functioning team for global regulatory and quality assurance (GxP).
RESPONSIBILITIES:
- In conjunction with product development strategies, develop and implement global regulatory strategies to optimize approval in US, EU, Japan, and ROW
- Develop, administer, and maintain programs and processes to ensure high quality products and compliance with current GXP - Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices for the product development pipeline
- Provide leadership to regulatory and quality professionals and build a highly capable team through the attraction, training, and development of the necessary skilled professionals to meet business needs
- Direct a wide variety of activities to ensure compliance with quality systems, quality procedures, quality policies, and applicable regulatory requirements to facilitate compliance with health authorities
- Maintain up to date knowledge of regulatory and quality initiatives for biopharmaceuticals
QUALIFICATIONS:
- A degree in a life science or closely related discipline with a higher degree strongly preferred (e.g., MSc, MPH, PhD)
- Minimum of 20 years of management experience in the biotechnology industry and 10 years in Regulatory/Quality/Project Management leadership positions
- Expert knowledge of US and international laws pertaining to drug development and commercialization, including GMP regulations
- Successful track record of leading global submissions (INDs, CTAs and NDA/MAA/JNDAs) and launch activities for novel products
- Experience in working in partnership with FDA, and global health authorities through various communication modes (written, telecon, video-conferencing, face-to-face)
- Experience with implementation and oversight of quality management systems
- Experience with regulatory inspections (pre-BLA)
SKILLS:
- Collaborative style with the vision to shape the regulatory and development pathways for Company products
- Proven ability to manage multiple complex projects, with the flexibility to adapt and reprioritize workload
- Adept at cross-functional team collaboration and management. Strong interpersonal skills and proven ability to contribute to a team environment
- Outstanding written, organization and communication skills
- Excellent management, coaching and mentoring skills
- Thrives in a fast-paced environment
The salary range for this position is $280,000 - $350,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.
Leila Johnston
Division Director