The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
We are currently searching for a senior-level Regulatory Sciences Project Manager; responsibilities include:
Formulate and execute regulatory strategy, author submissions, and provide support across multiple therapeutic areas.
Coordinate with US and international clients to provide regulatory strategy, guidance, and submission support.
Plan, write and prepare documents for submission to FDA and international Health Authorities supporting clients’ investigational and marketing applications.
Author and compile regulatory documents to support INDs, NDAs, BLAs, ANDAs and DMFs.
Support all activities related to FDA meetings.
Prepare FDA meeting requests and briefing packages to support milestone meetings.
Coordinate rehearsal meetings with sponsor based on preliminary responses received from FDA, and participate in FDA meetings on Sponsor’s behalf.
Monitor, prioritize and supervise multiple projects at different stages of development.
Proactively communicate with clients throughout the project to establish strategy and timelines, agree on content and format of the submission, review/assess submission documents, including gap assessment.
Represent companies as their designated Regulatory/US Agent.
Ensure compliance with regulations and applicable guidelines.
Provide leadership to the regulatory team members through training and mentoring.
The ideal candidate will possess the following qualifications (only candidates that meet the following criteria will be considered):
Knowledge of regulatory sciences as demonstrated through a combination of work experience and academic background:
Prior professional experience in pharma, bio tech, or medical devices companies.
Prior experience with regulatory submissions and interactions with the FDA or other Health Authorities.
Knowledge and experience with eCTD.
Interpret and apply regulations as they apply to specific project issues: 21 CFR, FDA, ICH, or other regulatory agency guidance requirements.
Experience in a consulting environment is a plus.
BS/BA in Regulatory Sciences or Life Sciences. RAC and/or MS/Ph.D. are a plus.
Project management skills: research, planning, scheduling, documentation, and project control.
Strong attention-to-detail, organization/multitasking, teamwork, and communication (verbal/written) skills.
Professional and courteous work demeanor in interactions with colleagues, clients, and regulatory authorities.
Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) and Adobe Acrobat.
Maintain company values and demands the highest standards of conduct from self and others.
Working at B&H Consulting Services, a VCLS Company, is more than just a job, we offer a career. B&H welcomes both junior and senior-level professionals alike, and joining the team means striving for excellence and true understanding of both the regulatory environment and how this evolving environment may affect the needs of our clients. If the promise of supporting the development of effective therapies and making them accessible to patients excites you, consider applying for this opportunity.
Additional Salary Information: Compensation package include benefits including health, dental, vision, FSA, life, disability, and 401K with safe harbor company match.
Internal Number: 2020USB05
About B&H Consulting Services, a VCLS company
Working at VCLS is more than just a job, we offer a career. VCLS welcomes junior and senior-level professionals alike, and joining the team means striving for excellence and true understanding of both the regulatory environment we evolve in and how this environment may affect the needs of our clients. If the promise of delivering effective therapies and making them accessible to patients excites you, consider applying for this opportunity.
Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets.
We provide actionable recommendations at every stage of the development process, enabling clients to make informed decisions. We offer hands-on assistance to develop briefing and submission packages, as we lead communication with regulators and payers.
Our Values: People, Innovation, Passion, Excellence