Associate Principal 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 an Associate Principal Consultant today!
In this role, you will be responsible for managing multiple regulatory programs for emerging life science companies, independently developing regulatory strategies and submissions, taking a leadership role in client, FDA and internal interactions.
- Serve as a regulatory advisor, regulatory lead, and/or project or program leader for multiple biotech and pharma company engagements, leading cross-functional teams in a variety of indications and/or product types in all stages of development
- Lead regulatory assessments, integrated development plans, and other documents to drive development sophisticated and/or unique assets and platform technologies
- Advise on, coordinate, lead, author, and/or review Health Authority meeting documents, special designation requests, and other regulatory submissions
- Lead and run interactions with Health Authorities on behalf of clients, including providing pre-meeting coaching and preparation, serving as Authorized Sponsor Representative to the FDA
- 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 fifteen years of Regulatory Affairs experience in a biotech and/or pharmaceutical industry
- Experience interacting with US and ex-US Regulatory Authorities
- Experience managing program level 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 $160,000.00 and $190,000.00 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.
We are committed to equal employment opportunities for all applicants and employees. We do not discriminate against employees or applicants for employment based on any protected class including, but not limited to, race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age, veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.
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.