Senior Consultant, Regulatory CMC
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 CMC today!
In this role, you will independently develop regulatory strategies and submissions for multiple sophisticated programs for emerging life science companies. This role will allow you to assume a dynamic leadership role to help both clients and Halloran continue to grow.
- Serve as a regulatory advisor, regulatory lead, and/or project or program leader for multiple emerging, development stage biotechnology and pharmaceutical company engagements
- Participate in cross-functional teams in multiple indications and/or product types focusing on Regulatory CMC activities
- Lead regulatory assessments, integrated development plans, and other strategic planning documents to drive development of clients’ assets and platform technologies
- Coordinate, lead, author, and/or review Health Authority meeting documents, special designation requests, sections of investigational and commercial submissions, and other regulatory submissions
- Lead and run interactions with Health Authorities on behalf of clients in formal meeting settings, including providing pre-meeting coaching and preparation
- Act as a project lead on complex, multi-disciplinary, interrelated projects; define project scope and plan and propose appropriate resource allocation options
- Supervise, analyze and report project status including results, budget, schedule, and resources, identifying impact of and mitigating any risks
- Communicate with internal and external partners regularly to build support and credibility and reflect goals, needs, and sensitivities of individual projects
- Educate existing and potential clients on Halloran services and opportunities for partnerships, authoring proposals and statements of work
- Participate in internal activities such as invoicing, bookings, process optimization, developing new product offerings and consulting services, and other internal initiatives
- Showcase your subject matter expertise by publishing articles, attending and speaking at workshops and conferences
- Mentor and lead internal Halloran team members to ensure success of company and client goals in a direct, project-based, or matrixed relationship
- Other duties and responsibilities as assigned
- Bachelor’s degree in a science field with at least twelve years of combined CMC and Regulatory Affairs experience in a biotech and/or pharmaceutical setting
- Proven history of leading Regulatory CMC strategic activities across all phases of development
- Experience interacting with Health Authorities
- 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 with multiple product types (small molecules, biologics, etc.)
The targeted gross compensation range for this position is between $150,000.00 and $180,000.00 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.