Senior Regulatory Affairs Strategist

Regulatory Affairs Baltimore, Maryland Southborough, Massachusetts San Bruno, California Morrisville, North Carolina


Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.


Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!




The Senior Regulatory Strategist plays a key role in providing expert consultation to Veristat’s 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.
 

As a Senior Regulatory Strategist You Will…

 

  • 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, 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, and publishers as needed.
  • Assist in business development efforts by contributing to project proposals, participating at 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 complete understanding of Veristat’s offerings and responsibilities.

 

Experience + Requirements
 

  • Bachelor’s degree in a related field required. Advanced scientific degree (i.e. PhD or Master’s degree) preferred.
  • 15 years of relevant experience with at least 10 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 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.