The Regulatory Affairs head will be a key leader of our management team and will provide management and leadership of the Regulatory Affairs to support the development and implementation of regulatory strategies and processes to secure worldwide product approvals.
The Regulatory Affairs head will work directly with Aspyrian’s functional leaders and external consultants and will lead the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.
Desired areas of expertise include the following:
- (i) clinical trial design including trial design for accelerated approvals
- (ii) pharmacovigilance and drug safety compliance
- (iii) regulatory submissions and discussions with the FDA, EMA and PMDA
- (iv) CMC/cGMP of biologics to support pivotal studies and commercial launch
- (v) device regulatory compliance for world-wide use
- (vi) requests for orphan designation, breakthrough designation, fast track, accelerated approval
- (vii) commercial launch and product promotional activities.
Understanding of Quality Assurance and Quality Management Systems will be valued and potentially the Regulatory Affairs head will be considered to oversee the Quality Assurance organization.
We are looking for a hands-on candidate with strong leadership kills, a candidate that thrives in a fast-paced, highly interactive, and non-bureaucratic start-up environment, a candidate with excellent interpersonal skills that is determined to execute under tight timelines, a candidate that is energized by our mission to provide the patients with transformative treatments so they can conquer their disease.
The Regulatory Affairs position will be based in Aspyrian’s San Diego corporate office, however, we may consider the flexibility to work remotely from the Bay Area as long as the candidate can visit frequently the San Diego corporate office. The Regulatory Affairs head will report directly to the President/CEO.
Key Duties and Responsibilities
- Provide management and leadership of the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
- Serve as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes
- Execute US /OUS regulatory project plans in collaboration with Aspyrian management, clinical, CMC and device groups as well as regulatory consultants, and CROs
- Manage and oversee of all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory FDA, EMA and PDMA applications, safety, amendments, and IND safety and annual reports
- Have and maintain awareness of existing and new regulations and guidance for quality, CMC, nonclinical and clinical matters, devices and advise on expectations and requirements for US and OUS compliance
- Oversee Quality Management Operations
- Provide counsel, training, and interpretation of FDA and other regulatory agencies to Company
- Contribute to Aspyrian corporate infrastructure via development of SOPs, work instructions, etc.
- Develop strategy and assure compliance of devices compliance with FDA regulations and the Medical Device Directive (MDD) in the EU and other equivalent regulatory requirements at other territories
- Responsible for the review and approval of promotional, advertising, and labeling items
- Other duties as assigned
Desired Education, Skills and Experience
- Minimum of 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization
- Experience in oncology programs and accelerated approvals
- B.S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly
- desired. RAC accreditation is desirable
- Experience in representing the sponsor and interfacing with the FDA, EMA and PDMA
- Demonstration of successful submissions of INDs, NDAs, BLAs and/or PMAs; experience with drug-device combinations is desirable
- Experienced in cGMP of biologics
- Extensive knowledge of US FDA/EMA drug/device development process, regulations and
- guidelines, including GCP. Solid knowledge of Quality Assurance and PAI preparations
- Good understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirement and SOP’s
- Good conceptual, strategic, analytical, problem solving, and organizational skills
- Ability to operate independently and proactively, to provide insight into specific regulatory issues within the context of the ongoing and future programs. To proactively undertake background research needed and to propose effective and creative solutions
- High emotional intelligence, sound temperament and professional attitude. Good common sense and judgment. Broad business perspective to integrate Regulatory Affairs concepts as part of the overall corporate strategy
- Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration
- Outstanding leadership and management capabilities to build, motivate and manage a strong quality organization. Personal alignment with Aspyrian’s values, mission and vision
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done
- Department: Regulatory and Leadership
- Type: Full-time
- Min. Experience: Executive