Clinical Research Regulatory Manager Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. Our client is a tech-enabled, next-generation CRO, that promises faster and higher-quality execution of trials. We are currently hiring a direct hire need for their Quality and Pharmacovigilance department. This role is fully remote, based anywhere in the US and offers a competitive total package for career longevity.
Head of Regulatory Affairs
San Francisco, CA - FULLY REMOTE
About The Organization – 1st Hand
An organization whose mission is to run clinical trials with faster execution and higher quality to bring new therapies to market. We are building infrastructure that powers faster execution of clinical trials and higher quality data. Our vision is to empower scientists to cure all human disease.
Our early team is made up of experienced technology and operations leaders from Apple, Google, Faire, Chime, TPG Capital and other leading technology companies.
We are founded in Oct 2020 and have grown the team to over 100 across all areas of the business. Come join us on our adventure to reimagine clinical trials.
What You'll Do
We are looking for a Head of Regulatory Affairs who will bring experience across multiple therapeutic areas of regulatory affairs and operations. This is a fully remote opportunity and can be either full-time or contract.
- Lead the Regulatory function to enable the measured growth and evolution as the company and pipelines grow
- Optimize CRO interactions and lead external regulatory CROs and vendors to drive excellence and meet phase-appropriate regulations and timelines
- Develop and manage Regulatory budgets
- Develop plans for growth of the regulatory function and hire, manage, and develop Regulatory personnel
- Develop and implement regulatory strategy across a growing pipeline of early- and mid-stage development programs
- Ensure effective risk management and communication of issues/risks across the portfolio, and participate in driving prioritization of resource and spend
- Oversee, plan, and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc), preparation and leading of agency meetings
- Serve as the company contact with the FDA and other regulatory authorities
- Perform all duties in keeping with the Company's core values, policies, and all applicable regulations
Who You Are
Preferred Experience and Qualifications:
- Bachelor's or more advanced degree in a scientific discipline
- 8+ years of regulatory experience in the CRO, pharmaceutical, or biotech industry.
- Experience working in a small biotech environment is highly preferred
- Ideally, experience across Oncology, GI, Central Nervous Systems, Ophthalmology, or Dermatology.
- Subject matter expert knowledge of US regulations
- Must be self-motivated and understand the risk and risk management in a small company environment
- Cross-functional collaborative skill set and brings strong analytical thinking and strategic perspective
Why You'll Love Working At Our Organization
We are innately curious. We found our calling in clinical trials after learning the pain points directly. It is our curiosity that propels us to keep building, finding new challenges, and fulfilling our vision of reimagining clinical trials.
We believe in autonomy. Team members do their best work when given autonomy. In order to make an impact on the scale of our organization's vision, we built our culture to enable each team member to feel ownership of their domain.
We take pride in building mastery. We believe in building master in a craft. Craftsmanship, a pride in one's craft, is key to prolonged engagement on a difficult challenge. Our culture is one of highly autonomous, deeply focused experts working on an immensely hard problem together.
Our strength is moving fast and staying humble. We believe that if we build a team that is intellectually honest, that we stay nimble and keep an open mind to all solutions - we'll be adaptive and solve the problems that face us at every turn.
Competitive Equity Compensation
Health, Dental, and Vision
Paid Parental Leave
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.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®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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 Kelly's 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.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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