Job details
Salary $130,000 - $195,000 a year
Full job description
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 submissionsYou 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 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
Qualifications:
Required:
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
Preferred:
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.)
Compensation:
The targeted gross compensation range for this position is between $130,000.00 and $195,000.00 annuallyPlease 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 employeesWe offer reimbursements for health & wellness programs and memberships, opportunities for continued learning through conference and continuing education programsWe also offer a self-managed pto policy, commuter fsa benefits, and many other benefits.
Halloran consulting group, incCovid-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 accommodationIndividuals 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.
Notice:
Halloran does not sponsor visas for employees.
All remote employees are expected to have a consistent connection to the internet while working remotely.
We are committed to equal employment opportunities for all applicants and employeesWe 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 employmentPlease 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
