Role

• Lead and contribute to the preparation, review, and submission of FDA (or similar agency) regulatory filings, such as PMTAs, SEs, MRTPs, responses to deficiency letters, and preparation of presubmission meeting materials

• Ensure that all submissions are grounded in strong science, aligned with overall product strategy, compliant with regulations, and well-written

• Lead collaborations with third party vendors supporting regulatory filings, including managing requests for proposals, vendor selection, drafting and reviewing study protocols, and ensuring that final study results are complete, accurate, and align with protocols

• Work with clients and prospective clients to develop regulatory strategy for product development, application, post-market surveillance, and commercialization

• Support the company’s growth initiatives by attending and presenting at conferences, building upon existing client relationships, and developing new clients and workstreams

• Contribute to organizational growth by optimizing processes and providing thought leadership on developing industry trends and regulatory changes

Education

• Master’s degree in life sciences or public health (PhD is a plus)

• Will consider bachelor’s degree with proven experience in shaping regulatory strategy and management of regulatory submissions

Experience

• 10+ years of experience working with FDA regulated products

• 5+ years of experience working with nicotine products supporting PMTA development, preparation, and/or regulatory affairs

• 5+ years managing teams and/or complex projects

• Work experience with the FDA (CTP or CDER) is a plus

Competencies

• Highly proficient in oral and written communications, correspondence, and presentations to technical and non-technical audiences, with strong editing skills

• Capable project manager skilled in managing complex projects with internal and external team members, performing work as an individual contributor and as a project manager

• Detail-oriented and organized

• Highly collaborative and adept in creating interpersonal relationships with other team members and clients in a remote working environment

• Curious, outside the box thinker interested in working on widely varying projects in diverse subject matter areas

• Experience presenting to audiences at seminars or conferences is a plus

• Demonstrated proficiency in developing and expanding client relationships is a plus