Senior Consultant, Regulatory Affairs

Posted 05 May 2022
SalaryUS$150000 - US$195000.00 per annum + benefits, bonus
LocationSan Diego
Job type Permanent
DisciplineLife Sciences
ReferenceBBBH132556_1651770730
Contact NameMelody Lam

Job description

Senior Consultant, Regulatory Affairs (Device/In Vitro Diagnostics)

*This is a full-time salaried position with benefits

In this role, you will be responsible for managing multiple regulatory programs, independently developing regulatory strategies, and leading the preparation of regulatory submissions. You will take a leadership role in interacting with the FDA, interact with potential clients in a business development role, and ensure consistent high-quality delivery of client goals.

Characteristic Duties:

  • Serve as a regulatory advisor, regulatory lead, and/or project or program leader for multiple medical device, in vitro diagnostic, and other sponsor engagements as your expertise allows
  • Lead cross-functional teams in multiple indications and/or product types in all stages of development; lead regulatory assessments, integrated development plans, and other documents to drive development of clients' assets and platform technologies
  • Coordinate, manage, author, and/or review Health Authority meeting documents, special designation requests, and other regulatory submissions
  • Lead interactions with Health Authorities on behalf of clients in formal meeting settings, including providing pre-meeting coaching and preparation, serving as Authorized Sponsor Representative to the FDA
  • Provide expertise in strategic interpretation of Health Authority regulations, guidance and directives to develop regulatory strategies and sound regulatory submissions
  • Act as a project lead on multi-faceted, multi-disciplinary, interrelated projects by establishing project plan, budget and methodology, proposing appropriate resource allocation options that ensure team and client happiness and success, guiding team members as needed
  • Supervise, analyze and report project status, determining the impact of and mitigating any risks, developing appropriate messaging for regular communication with partners
  • Educate existing and potential clients on services and opportunities for new and continued partnerships
  • Provide early input and participate in project scope definition and proposal/statement of work authoring
  • Participate in internal activities such as invoicing, bookings, developing new product offerings and consulting services, publishing articles, presenting/moderating workshops, attending conferences when opportunities arise and serving on process optimization and other initiatives
  • Mentor and manage internal team members (up, down, and across the organization) to ensure success of company and client goals, either in a direct management, project-based, or matrixed relationship
  • Other duties and responsibilities as assigned

Qualifications:

Required:

  • Bachelor's degree in a science field with at least twelve years of Regulatory Affairs experience in a medical device, in vitro diagnostic, or other related life science setting
  • Regulatory interaction experience with US and ex-US Authorities
  • Experience supporting program level strategic activities spanning from IDE through marketing approval
  • Deep familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
  • Ability to balance multiple priorities and sophisticated issues using logical, creative, analytical, and efficient processes with a high level of attention to detail and quality of work
  • Exercise good judgment in selection methods, techniques and evaluation criteria for issues that may require in-depth evaluation of variable factors

Preferred:

  • Advanced Education and/or Certifications
  • Prior Consulting experience
  • Experience with other product types (drugs, biologics, etc.)

Benefits and Perks:

The benefits of being an employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. We offer reimbursements for Health & Wellness Programs and Memberships, opportunities for continued learning through conference and continuing education programs. We also offer a Self-Managed PTO Policy, Commuter FSA Benefits, and many other benefits.

COVID-19 Considerations:

Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering offices, attending sponsored events (at offices or otherwise), and traveling to client sites, subject to requests for accommodation. Individuals will be considered fully vaccinated two weeks after a second shot of a two-shot vaccine regimen (i.e., Pfizer or Moderna) or two weeks after a single shot of the Johnson & Johnson vaccine.