Sr. Manager/Associate Director, Regulatory
Antiva Biosciences, Inc. is a privately held San Francisco Bay Area-based biopharmaceutical company focused on the development of antiviral therapies. The company is using a new medicinal chemistry platform to develop antiviral therapies, focusing initially on Human Papillomavirus (HPV). Antiva’s lead compound, ABI-1968, is a topical antiviral for the treatment of lesions resulting from HPV infection, the primary cause of cervical and anal cancer.
Reporting to the Chief Medical Officer (CMO), the Sr. Manager/Associate Director, Regulatory serves as an in-house person and contributes to the global Regulatory Affairs registration strategy and submissions plan to support clinical development of a topical, non-absorbed new molecular entity (NME) with two indications actively under study.
This position will serve as a direct point-of-contact for FDA, with overall responsibility for the delivery of regulatory submissions in compliance with global health authority requirements. This individual will be responsible for:
· providing guidance to cross-functional teams on regulatory strategy and tactics,
· the timely planning, coordination and submission of regulatory filings, and
· oversight of the regulatory operations function and management of external vendors responsible for ensuring timely submissions of the highest quality
Essential Duties and Responsibilities:
- Represent Regulatory Affairs on global project teams and task-specific subteams. Manage all aspects of the implementation of the defined regulatory strategy and support to the project team for an assigned project, under the guidance of the CMO. Serve as a point-of-contact for FDA.
- Provide strategic input and function as the regulatory lead for an assigned project, offering guidance/advice to the project leader and project team on regulatory matters.
- Participate in meetings with regulatory authorities, as appropriate.
- Manage the regulatory work of CROs and consultants in the preparation of regulatory submissions and information necessary to obtain Regulatory Authority clearance for clinical studies.
- Responsible for the review of clinical study documents, site regulatory packages, and development reports in support of the assigned project.
- Responsible for the routine surveillance of changes in regulatory landscape (e.g., new and revised guidance documents, advisory committee transcripts, or relevant regulatory precedent products, etc.) and subsequent dissemination / training of the project team
- Manage the archival of regulatory correspondence and intelligence documents and perform the review of internal SOPs on behalf of the Regulatory department.
- May provide due-diligence support for partnering and licensing activities.
- Bachelor of Science (B.S.) degree
- At least 8 years of pharmaceutical industry experience, specifically in human drug development on behalf of an industry-sponsor.
- A minimum of 5 years of direct experience in regulatory affairs
- Thorough knowledge of the drug development and regulatory submission processes
- Prior experience supporting a clinical development project team for investigational projects in Phase 0-3; authoring FDA submissions that include complex or technical content of a clinical, nonclinical and manufacturing nature.
- Experience serving as a point-of-contact for FDA and prior responsibility for regulatory operations
- Proficiency with MS Office Suite
- Excellent verbal, written communication and presentation skills.
- Excellent interpersonal skills with an ability to effectively work within a multi-disciplinary team and to effectively support multiple activities in a fast-paced environment.
- Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
- Adaptability, flexibility, independence and resourcefulness to roll-up sleeves and multi-task to thrive in a small company environment.
- Proven track record of successfully delivering investigational-phase regulatory submissions on time, within budget, and at the required quality.
- Ability and willingness to effectively manage conflicts and achieve results.
Antiva provides very competitive benefits and compensation plans including incentive-based compensation as well as a collegial, collaborative, entrepreneurial environment committed to improving global health outcome for individuals with HPV-related diseases. Qualified candidates may submit their resumes to email@example.com