Key Purpose:

The Regulatory Strategist plays a key role in providing 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 strong rapport with clients.

 

Primary Duties + Responsibility:

• Provide 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 and third-party vendors.
• 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).
• Assist in business development efforts by contributing to project proposals.
• 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) with support from management as needed.
• 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) with support from management as needed.
• 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.

• 10 years of relevant experience with at least 5 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting required with a proven track record of global regulatory submissions, and strong relationships with the regulatory agencies.
• Knowledge of International Conference on Harmonization (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.
• Demonstrated ability to develop and foster positive client relationships.
• 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

 

Posted On: Wednesday, July 20, 2022