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 team as a Senior Consultant 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.

Characteristic Duties

• Serve as a regulatory advisor, regulatory lead, and/or project or program leader for multiple biotechnology and pharmaceutical sponsor engagements
• Provide expertise in strategic interpretation of Health Authority regulations, guidance and directives to develop regulatory strategies and sound regulatory submissions
• Breadth and depth of regulatory leadership experience from multiple indications and product modalities
• Serve as regulatory lead in client cross-functional teams in all stages of development, regulatory gap assessments, integrated development plans, and other workstreams to drive development of clients' assets and platform technologies forward
• Direct a client’s regulatory strategy in accordance with applicable regulations and guidelines to enable high quality regulatory dossiers to permit clinical development to progress
• Coordinate, manage, author, and/or review Health Authority meeting documents, special designation requests, regulatory applications (i.e. INDs / CTAs/ NDAs / BLAs etc.) and other regulatory submissions
• Confirm consistent strategic messaging and cohesion throughout regulatory dossiers
• Develop regulatory roadmaps to key development inflection points based on client’s needs
• Identify regulatory risks and mitigation strategies
• Willingness to serve as the regulatory lead on client programs where first-hand experience with product modality and/or indication was not obtained
• 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
• Act as a project lead on multi-faceted, multi-disciplinary, interrelated projects by establishing project plan, budget and methodology, 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
• Participate in business development / sales calls and provide input on 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 nine to twelve years of Regulatory Affairs experience in a biotech and/or pharmaceutical setting
• Practiced 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
• Understanding of Microsoft Office (Excel, PowerPoint, Word) and Adobe
• 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
• Apply innovative ways of thinking and solutions towards development challenges our clients may be facing
• 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 rare disease, neurology, 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 $175,000.00 and $205,000.00 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.