Principal Regulatory Strategist (Contract)

Company: Precision Life Sciences
Location: Cambridge
Posted on: June 23, 2022

Job Description:

Job DescriptionThe Principal Regulatory Strategist independently provides expert consultation clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will serve on project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create a strong rapport with clients. The Principal Regulatory Strategist acts as a point of escalation for challenging regulatory issues and serves as a mentor to junior team members. Primary Duties + Responsibility: Independently provides consulting services in regulatory program strategy, overall drug development plans, strategic regulatory communications, and FDA representation.Oversee the Regulatory Affairs aspects of client projects and project teams through the coordination of internal staff, third-party vendors, and interaction with Executive-level staff.Write, review, and provide strategic regulatory guidance on alternative pathways, such as fast track, breakthrough (and other expedited programs), orphan, and 505(b)(2), and corresponding pathways in Europe (in collaboration with EU strategist/consultant).Mentor and train associates, specialists, publishers, and strategists as needed.Assist in business development efforts by contributing to project proposals, participating in bid defense meetings, and performing client presentations as requested.Prepare clients for FDA meetings, and as contracted, serve as authorized regulatory representative.Provide strategic and regulatory compliance reviews of documents for marketed products, including marketing materials, Field Alert Reports, Individual Case Safety Reports, and Periodic Safety Updates.Author, direct and provide strategic guidance to regulatory submissions worldwide (IND, NDA, BLA, MAA, PMA, CTA; both original applications and amendments).Provide peer review for investigator brochures, clinical study reports, clinical protocols, and other documents as required, and contribute to the creation of strategic Clinical Development Plans (CDPs).Prepare and present at internal and client meetings as needed to provide regulatory guidance.Provide a high standard of customer service and ensure a complete understanding of offerings and responsibilities. Experience & Minimum Requirements: Bachelor's degree in a related field required. Advanced scientific degree (i.e. Ph.D. or Master's degree) preferred.20 years of relevant experience, with at least 15 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting required (or demonstrated ability to function at this level), with a proven track record of global regulatory submissions, and strong relationships with the regulatory agencies.Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.Experience serving as an authorized regulatory representative required, with a demonstrated ability to integrate scientific and business objectives to ensure a positive commercial outcome from health authority negotiations.Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required.In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.Demonstrated ability to develop and foster positive client relationships.Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.Skilled in the use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment. Additional Requirements:Driving/Travel requirements - 0-20% (US, Canada, International)Physical requirements - Ability to occasionally lift/move up to 25 lbs.FLSA Classification - Exempt

Keywords: Precision Life Sciences, Cambridge , Principal Regulatory Strategist (Contract), Other , Cambridge, Massachusetts