Vice President, Global Regulatory Affairs

Kellyu00ae Science & Clinical is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late clinical-stage, innovation-driven Biotech client. If youu2019re passionate about shaping regulatory strategy and compliance for breakthrough therapiesu2014and are ready to make an impact in a high-growth environmentu2014trust The Experts at Hiring Experts. Title: Vice President/Senior Vice President, Global Regulatory Affairs Pay: $300,000-$400,000 per year, plus industry competitive compensation, bonuses, stock options, and employee stock purchase plan FT or PT: Full-time Location: Remote (anywhere within the continental U.S.) Key Responsibilities: + Lead global regulatory strategy for assigned product(s), ensuring plans meet global regulatory requirements + Develop, strategize, and submit regulatory documents, including NDA, IND, and other health authority submissions with cross-functional teams + Lead planning, preparation, and conduct of Health Authority meetings, ensuring optimal outcomes + Identify and assess regulatory risks and provide technical regulatory guidance to internal stakeholders and C-suite executives + Review and approve all submission documents, including clinical study protocols, reports, statistical analysis plans, investigator brochures, and development safety update reports + Support submission strategy for CMC and non-clinical information + Mentor and develop a high-performing regulatory affairs team and foster a collaborative work environment + Act as the primary point of contact with FDA and other global health authorities + Stay current with evolving global regulatory requirements and provide training to internal stakeholders Qualifications: + Advanced degree in science (Ph.D., MD, PharmD) in a relevant scientific discipline + 15+ years of industry experience, with at least 10+ years of progressive leadership in regulatory affairs within biotech or pharma + Recent, successful NDA submission and approval experience preferred + Expertise with US FDA regulations and global health authority policies + Exceptional leadership, communication, negotiation, and stakeholder engagement skills Compensation & Benefits: + Industry competitive compensation + Performance-based bonuses and stock options + Employee Stock Purchase Plan and 401k plan + Comprehensive healthcare coverage including medical, dental, and vision for employees and dependents + Flexible and remote work options with unlimited paid time off + Paid holidays, mental health days, and winter shutdown + Support for work-life balance with a collaborative and innovative work culture Physical Demands: + Ability to travel up to 15-20% (US and international) + Flexible hours may be required + Reasonable accommodations available for individuals with disabilities This opportunity is ideal for a strategic leader with deep expertise in regulatory affairs who thrives in a collaborative, mission-driven environment at the forefront of biotech innovation As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly u00ae Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifeu2014just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2025-11-20