Lead Consultant, Regulatory Operations
Lead Consultant, Regulatory Operations
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 Lead Consultant, Regulatory Operations today!
In this role, you will be responsible for leading the formatting, technical revision, and publishing of regulatory submissions and marketing applications to Health Authorities. As we launch our Regulatory Operations in-house, you will serve as one of the key users and trainers of the publishing system, helping to educate and elevate the Regulatory Operations group.
- Manage the Regulatory Operations aspects of all Health Authority submissions for Halloran’s biotechnology, pharmaceutical, and/or medical device company engagements, including the planning, management, and execution of submissions
- Be responsible for the maintenance of tracking tools for planned, current and past regulatory submissions; liaise with Regulatory leads to ensure appropriate planning for submissions
- Provide guidance on the technical editing of electronic submission output and publishing standards, both through hands on training and the development of reference guides and tools for submissions
- Manage the creation and maintenance of custom templates, style guides, document libraries, reference guides, and tools for various aspect of document management and submission creation, review, validation, and transmission
- Assess current Halloran systems and take leadership role in proposing and implementing new aspects for regulatory processes, including assisting in the onboarding and training of employees on Docubridge
- Establish project scope, expectations, plan, and details that ensure high quality, timely and in budget results
- Supervise, analyze, and report project status, utilizing appropriate communication methods to update and solicit approval from internal, vendor and client partners
- Identify, mitigate and analyze the impact of any project risks, supporting timely resolution and client-facing response
- 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, developing new product offerings and consulting services, serving on internal process optimization activities and speaking publicly at conferences and workshops
- Train, mentor and lead internal Halloran team members to ensure success of company and client goals, in direct management, project-based, or matrixed relationships
- Other duties and responsibilities as assigned
- Bachelor’s Degree and a minimum of ten years of experience in Regulatory Operations in a biotechnology or pharmaceutical setting
- Experience with Docubridge, and management and submission of Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND) Datasets and Structured Product Labeling (SPL) documents
- Familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
- High proficiency in Microsoft Word, Excel, Adobe Acrobat Professional, Project, and PowerPoint
- Ability to work creatively and analytically to balance multiple priorities, tasks, and sophisticated issues using logical and efficient processes
- Exercise good judgment in selection methods, techniques and evaluation criteria for sophisticated, complex issues that may require in-depth evaluation of variable factors
- Advanced Education and/or Certifications
- Prior Consulting experience
- Experience with implementing new document management/publishing systems
- Experience interacting with publishing companies
- Ex-US Health Authority Submissions (Health Canada, EMA, etc.)
The targeted gross compensation range for this position is between $135,000.00 and $170,000.00 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.