Senior Consultant, Regulatory CMC (Cell and Gene Therapies)

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 manage multiple regulatory programs for development stage biotech companies to guide, develop, and lead regulatory development strategies and submissions. You will take a leadership role in CMC Regulatory guidance, provide strategic interpretation of Health Authority regulations, and ensure clients goals are met through consistent high-quality deliverables.

Characteristic Duties:

• Serve as a regulatory advisor, CMC regulatory lead, and/or project or program leader for multiple biotechnology sponsor engagements.
• Lead strategic development planning to support emerging life science companies pursing early to late-stage development of cell and gene therapy products.
• Lead cross-functional teams focusing on Regulatory CMC activities 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 or contribute to CMC-focused interactions with Health Authorities on behalf of clients for relevant responses or queries.
• 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.
• Serve as an account champion, focusing on client success and meeting clients where they are at in their product development lifecycle.
• Provide early input and subject matter expertise to support engagement with potential clients throughout the sales cycle including project scoping and input to proposals/statements of work.
• 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 lead 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 a minimum of nine to twelve years of combined CMC and Regulatory Affairs experience in a biotech and/or pharmaceutical setting.
• Technical depth and understanding for novel biologic products and advanced therapies, including cell therapies, gene therapies, and LNPs or Exosomes, etc. is strongly preferred.
• Experience authoring INDs, DMFs, BLAs, IMPD, and Annual Report Updates, reviewing regulatory dossiers, and performing gap assessments.
• Proven history of leading Regulatory CMC strategic activities across all phases of development.
• Experience supporting program level activities across early development for cell and gene therapies, including pre-IND and IND submissions.
• Strategic contributions and guidance towards development and manufacturing plan, including DS suitability, process controls, analytical methods and specifications, stability protocols, and oversight/selection of CDMO partners.
• 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.
• Ability to work independently.
• 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 with multiple cell and gene therapy product types including viral vectors, lipid nanoparticle formulation, extracellular vesicles, exosomes, etc. 

Compensation:

The targeted base compensation range for this position is between $170,000.00 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.