Director of Regulatory Affairs
Director of Regulatory Affairs
NJOY is one of the largest independent vaping companies in the U.S. and a leader in the revolution against combustible cigarettes. With a clear mission to Make Smoking History, NJOY offers a range of electronic nicotine products for adult smokers and vapers looking for an alternative.
The brand was founded in 2006 and has continued to serve as a pioneer and thought leader in the vaping category. NJOY holds a contract with the National Institute of Drug Abuse (NIDA) to supply a standard research electronic cigarette for use in independent, government-funded clinical studies – a project with enormous potential in the United States and across the world.
NJOY is looking to expand the team with a Regulatory Affairs professional experienced in CMC in pharmaceutical or medical devices applicable to NJOY’s product analysis and manufacturing related programs. This hire will support our existing team in the execution of NJOY’s regulatory programs and other scientific work as required. This role will work in close collaboration with other NJOY team members, external specialist and preferred providers, in driving key parts of regulatory programs.
- Contribute to regulatory strategies that expedite the preparation, maximize the probability of success, and mitigate risks for NJOYs submissions to FDA.
- Ensure CMC-related regulatory requirements and strategy are understood by project teams.
- Assist with a broad set of regulatory responsibilities that may be operational in nature.
- Liaise with external experts and specialist suppliers to secure excellence in deliverables critical to project plans to meet agreed timing, cost, and standard of work.
- Coordinate and support the preparation of responses to information requests from regulatory agencies.
- Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables.
- Experience within FDA regulated products in the biotechnology, medical device, pharmaceutical, or life science consumer products organization(s) leading to premarket submissions with a track record of approvals.
- 6 years of experience in the biotech, medical device, or pharmaceutical industry.
- Bachelor’s degree in a life-science/ analytical field or equivalent.
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership.
- Ability to thrive in a collaborative and fast-paced environment with a willingness to wear multiple hats when necessary.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Advanced in Microsoft Office products (Word, Excel, PowerPoint).
- Ability to influence without direct authority.
- Demonstrated ability to manage external vendors/consultants.
- Ability to interact and effectively communicate professionally with all levels of the organization.
- Experience with tobacco products or Electronic Nicotine Delivery Systems (ENDS) is not a requirement but is a plus.
- Master’s, or Ph.D. degree in a life-science/ analytical field or equivalent.
- Track record of receiving FDA.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented appropriate and clear and conclusions are adequately supported by data.
NJOY is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. NJOY is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including pregnancy), national origin, age, disability, marital status, sexual orientation, genetic information, uniform service member or veteran status, or any other characteristic protected by federal, state or local law. Further, NJOY complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. NJOY is an e-verify employer.
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Job posted: 2020-06-11