- Job Type: Full-Time
- Function: Regulatory Affairs
- Industry: Therapeutics
- Post Date: 05/23/2023
- Website: icosavax.com
- Company Address: 1930 Boren Ave, Suite 1000, Seattle, Washington 98101, US
About IcosavaxIcosavax is focused on developing safe and effective vaccines against infectious diseases that address important unmet medical needs and reduce healthcare costs. The company was founded on breakthrough computationally-designed virus like particle technology, exclusively licensed for a variety of infectious disease indications from the Institute for Protein Design at the University of Washington. Icosavax is located in Seattle.
Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases.
The Sr Director, Regulatory Affairs will report to the SVP, Regulatory Affairs. She/he is responsible for contributing to the Icosavax regulatory strategy and will work closely with functional leaders in preparation of regulatory submissions, planning and executing the required regulatory interactions and activities for the development of our vaccine programs. He/she will be part of a cross-functional project team that helps to drive and support continued levels of success. The successful candidate will excel in a dynamic, small-company environment.
- Serve as the global regulatory lead for select programs. Oversee the successful regulatory strategy for development and registration of select candidate vaccines.
- Lead cross functional activities related to regulatory program strategy including providing input on implications of regulatory strategy, planning and coordination development of documents supporting regulatory submissions and interactions through participation in project team meetings.
- Create vaccine regulatory strategy to support integrated product development plans, leading to the successful completion of regulatory filings, including INDs, CTAs, IMPDs, and future biologics licensure and marketing authorization applications.
- Execute regulatory strategy including coordination of regulatory communications with competent authorities in multiple jurisdictions, successful regulatory submissions, and pursuit of appropriate regulatory indications for candidate vaccines.
- Maintain awareness of international regulatory legislation, review applicable regulatory proceedings, and assess their strategic impact on Icosavax development programs.
- Provide regulatory leadership on cross-functional project teams. Lead coordination, preparation, and successful resolution of regulatory interactions (e.g., submissions, scheduled meetings, regulatory correspondence, inspections).
- Demonstrate In depth knowledge and application of global regulatory guidance regarding investigational new drug (IND), clinical trial applications (CTAs), biologics license applications (BLAs), and post approval changes.
- Accountable for the delivery of all regulatory milestones for high-complexity biologics, including assessment of the probability of regulatory success and risk mitigation measures.
- Lead development and execution of detailed, global regulatory submissions of INDs, CTAs, BLAs, or post approval change documentation according to defined timelines.
- Collaborate with external partners, including consultants, CROs, and contractors, in critical review of submissions, and provide oversight to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Review detailed scientific information and ensure technical arguments are presented clearly and conclusions are adequately supported by data.
- Understand and translate regulatory requirements of GXP-related fields (e.g., manufacturing, analytical, quality assurance, nonclinical, and clinical development).
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Able to roll up sleeves/respond to dynamic change. Be flexible in responding to changing priorities or dealing with unexpected events.
- Demonstrate superior oral and written communication skills in multicultural settings and succinctly communicate complex regulatory information and tactical issues to key stakeholders.
- Strong listening skills and attention to detail.
- Demonstrate effective leadership, interpersonal, and negotiating skills with cross functional partners and health authorities.
- Contribute to a high-integrity, high-performance and enjoyable team culture.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s degree or Master’s degree in a biological science, engineering, or a related field (e.g. chemistry, immunology)
- 15+ years of relevant Regulatory experience, ideally within vaccine or biologics development. Minimum 3 years in another area of biopharmaceutical product development (e.g., manufacturing, analytical, quality assurance, nonclinical, or clinical development) preferred.
- Regulatory Affairs Certification (RAC) or other regulatory certification preferred.
- Manual dexterity required to operate office equipment.
- Some travel may be required.
- Location: Remote USA
- Must be eligible to work in the USA
- May require 10-20% offsite travel
- To reduce the presence and severity of COVID-19 cases in the workplace and in our communities, Icosavax requires all newly hired employees to be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state and local law
The salary range for this position is $230,000 – $290,000 per year; the base salary will be determined based on knowledge, skills, education, experience relevant to the role and location. This role is also eligible for bonus and equity compensation. Employees are offered health insurance (medical, dental, vision), health savings account with company contribution, flexible spending account, life insurance, short- and long-term disability, employee stock purchase plan, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.