Consultant, Regulatory Affairs - Halloran Consulting Group

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 team in the Consultant, Regulatory Affairs role today!

In this role, you will partner with client companies to execute Regulatory strategies and submissions, from pre-IND through market approval and ensure consistent high-quality client results.

Characteristic Duties:

• Partner with biotechnology and pharmaceutical companies to execute regulatory development strategies and submissions
• Provide regulatory support to life science companies pursuing early to late-stage development in a variety of indications and product types. Support includes:
  • Facilitate both internal and external client meetings through generation of meeting agendas and meeting minutes
  • Project manage internal and external teams towards meeting regulatory commitments and submission deadlines via use of tracking tools and templates
  • Administer, analyze, and report project status, utilizing appropriate communication methods to update and solicit approval from internal and client partners
  • Identify, mitigate and analyze the impact of any project risks, supporting timely resolution and client-facing response
  • Author and/or review Health Authority meeting documents, special designation requests, investigational and commercial regulatory submissions, and other regulatory documents.
  • Create and maintain Health Authority correspondence logs and archive Agency correspondence and submissions
  • Compile final documents for publishing activities to enable electronic submissions to Health Authorities
• Execute on project scope, expectations, plan, and details that ensure high quality, timely and in budget results
• Educate existing and potential clients on Halloran services and opportunities for partnerships
• Participate in internal activities such as invoicing, bookings, developing new product offerings and consulting services, serving on internal process optimization activities and speaking publicly at conferences and workshops
• Mentor internal Halloran team members to ensure success of company and client goals
• Other duties and responsibilities as assigned

Qualifications:

Required:

• Bachelor's Degree and a minimum of five to eight years of experience in Regulatory Affairs in a biotechnology or pharmaceutical setting
• Familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
• Ability to work creatively and analytically to balance multiple priorities, tasks, and sophisticated issues using logical and efficient processes
• Understanding of Microsoft Office (Excel, PowerPoint, Word) and Adobe
• Exercise good judgment in selection methods, techniques and evaluation criteria for sophisticated, complex issues that may require in-depth evaluation of variable factors

Preferred:

• Advanced Education and/or Certifications
• Prior Consulting experience
• Experience in rare disease, neurology, oncology, Immuno-oncology, and/or cell/gene therapy
• Experience with multiple product types (small molecules, biologics, devices, etc.)

Compensation:

The targeted gross compensation range for this position is between $130,000.00 and $160,000.00 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. As of January 2020, Halloran is proud to say we’re partially Employee Owned. Our Employee Stock Ownership Plan (ESOP) allows employees who meet plan entry requirements to own a piece of the company without having to invest their own money to purchase stock. In addition to this, Halloran offers a Self-Managed PTO Policy, opportunities for continued learning through conference and continuing education programs, and many other benefits.

Notice:

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.