Senior Consultant, Regulatory Affairs
Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Regulatory Affairs team as a Senior Consultant, Regulatory Affairs today!
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.
- Serve as a regulatory advisor, regulatory lead, and/or project or program leader for multiple biotechnology and pharmaceutical sponsor engagements
- 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 Halloran 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 Halloran initiatives
- Mentor and manage internal Halloran 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
- Bachelor’s degree in a science field with at least twelve years of Regulatory Affairs experience in a biotech and/or pharmaceutical setting
- Regulatory interaction experience with US and ex-US Authorities
- Experience supporting program level strategic activities spanning from pre-IND 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
- Advanced Education and/or Certifications
- Prior Consulting experience
- Experience in oncology, Immuno-oncology, and/or cell/gene therapy
- Experience with multiple product types (small molecules, biologics, etc.)
The targeted gross compensation range for this position is between $130,000.00 and $195,000.00 annually. Please note: this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.
Halloran Benefits and Perks:
The benefits of being a Halloran 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.
Halloran Consulting Group, Inc. COVID-19 Considerations:
Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering Halloran’s offices, attending Halloran sponsored events (at Halloran 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.
Halloran does not sponsor visas for employees.
All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.
Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws).
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by an authorized representative of Halloran.