Description
Unlock Your Expertise in Cutting-Edge Gene Therapy as a Part-Time Clinical Regulatory Affairs Lead
Are you a seasoned regulatory professional with a passion for innovative therapeutics? Join our client's dynamic team as a part-time Clinical Regulatory Affairs Lead and play a pivotal role in advancing groundbreaking gene therapy programs. This remote opportunity offers the flexibility to leverage your strategic expertise in guiding clinical-stage projects through complex regulatory pathways, ensuring compliance and accelerating patient access to life-changing treatments.
In this role, you will oversee the transition of regulatory responsibilities from investigator-initiated trials to sponsor-led studies, manage IND lifecycle activities, and serve as the key liaison with FDA and other health authorities. Your strategic leadership will directly impact the success of a promising gene therapy entering Phase I trials, making it an exciting opportunity for a regulatory expert eager to influence innovative science at every stage.
Required Skills:
- Extensive experience with IND submissions, amendments, and FDA negotiations
- Proven track record working with gene therapy or advanced biologics
- Deep understanding of clinical trial sponsor regulatory expectations during transition phases
- Strong knowledge of Phase I clinical trial regulations and safety reporting
- Excellent written and verbal communication skills for formal agency interactions
- Ability to work independently in a remote environment with minimal supervision
- Strategic mindset with the ability to translate complex regulatory requirements into actionable plans
Nice to Have Skills:
- Experience managing regulatory aspects of viral vector manufacturing and shedding studies
- Knowledge of global regulatory requirements, including EMA and other regional authorities
- Prior leadership experience in cross-functional teams within a biotech or pharma setting
- Familiarity with long-term follow-up (LTFU) requirements for gene therapy products
Preferred Education and Experience:
- Bachelor's degree in Life Sciences, Regulatory Affairs, or related field; advanced degree preferred
- 7+ years of regulatory affairs experience in biotech or pharmaceutical industries, with a focus on biologics or gene therapies
- Demonstrated success leading IND submissions and interacting with regulatory agencies at a senior level
Other Requirements:
- Remote work environment with reliable internet connection
- Availability to dedicate approximately 20 hours per week
- Comfortable managing multiple regulatory deliverables and timelines independently
Take this chance to contribute your expertise to innovative gene therapies that are transforming lives. Apply now and be at the forefront of regulatory strategy in a fast-moving, impactful industry!
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® 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 world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's 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, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's 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 life—just 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 California's 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.
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