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, US Regulatory Affairs, Worldwide Regulatory Affairs
Join our distinguished team of Subject Matter Experts who have a wealth of Industry and FDA experience, and partner with our clientele to deliver your Technical Expertise in support of novel therapies and treatments!
Parexel Regulatory Consulting is growing and we're seeking experienced Nonclinical Regulatory professionals who are passionate about drug development and looking for opportunities to stretch their thinking, advance professionally, and provide expertise, solutions, and strategy to various clients on exciting products in various stages of development.
A Principal Consultant within Parexel’s Regulatory Consulting Services team (RCS) must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. Must have the ability to develop a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services RCS provides. Provides a full range of consulting services supporting the development and delivery of IND, CTA, NDA, BLA, MAA, ANDA. Provides mentoring and guidance to junior team members on Nonclinical topics and/or business issues and supports knowledge-centered activities within RCS.
Produces quality work that meets the expectations of RCS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RCS are met. Manages project engagements (small or large)
Works within a team environment or individually based on the project needs. Works within broad project guidelines and facilitates issue and conflict resolutions.
Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives
Provides guidance to project team members and acts as a mentor to junior staff
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
Interacts with the assigned Project Specialist (PS) to ensure accurate financial management and for general project support
Delivers presentations at seminars and industry group meetings
Authors articles for publication in industry magazines, newsletters, book chapters and other forums
May serve as a member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
Drives knowledge-centered activities within RCS as well as contributes to Parexel business process improvements. May contribute to new service and consulting model development
Consulting Activities and Relationship Management and Business Development
Applies the appropriate organization’s consulting models and methodologies and assists in the design/improvement the methodologies when needed
Provides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agencies
Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
May act as a trusted advisor to clients, often on issues that lack precedence or are not clearly defined. May act as a loaned executive for a client
Facilitates resolutions to possible problems or conflicts within the project team and/or the client. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Develops business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry drivers
Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization
Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RCS management and account management
Actively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management. Presents information about RCS service offerings reflecting the organization’s capability to support client needs
Generates new or repeat business due to personal name recognition or history of client satisfaction and/or relationship
Leverages rainmaking skills resulting in new and repeat business for Parexel. Is responsible for constant monitoring of his/her “A” list, and is expected to have continued contact with both existing and future potential clients
Participates in project scoping calls and proposal preparation, delivers sales presentations and participates in bid defense meetings when needed. Actively participates in account planning for key clients
Education - PhD required
Language Skills - At least fluent vocal and written English
Minimum Work Experience - Numerous years’ experience with expert level regulatory knowledge in nonclinical development/toxicology with significant experience conducting gap analysis, developing regulatory strategy, preparing and/or reviewing nonclinical sections of US regulatory submissions, etc.
Significant previous experience with a regulatory agency (such as the FDA or MHRA) in Nonclinical/Toxicology Review or previous CRO, Pharma Industry, or Consulting Services experience providing strategic regulatory advice and driving major regulatory submissions (INDs, CTAs, MAAs).
Travel Requirements – 15-20% Domestic or International travel may be required
Telecommuting is allowed.
Internal Number: 69064BR
At the heart of getting medicines to those who need them.
Parexel is in the business of improving the world’s health. As a leading global clinical research organization (CRO), we provide a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
Headquartered near Boston, Massachusetts and in Durham, North Carolina, and supporting clients in more than 100 countries, our almost 16,000 employees are united by one simple fact. We care. We’re not just the people with brains, we’re the people with heart.
Making the most of every piece of the regulatory puzzle.
When it comes to clinical development, we’re dedicated to getting every moment right. And we have the people to get you there. The seasoned advisors on our Regulatory Consulting Services team have decades of experience helping teams interpret new and existing guidance throughout the process – and throughout the world. In fact, many of them are former FDA, EMA, and NMPA regulators themse...lves.
Our Regulatory Consulting Services include:
Regulatory Strategy: Global product development strategy, clinical, non-clinical, CMC, and regulatory gap analysis, due-diligence, product and indication prioritization, regulatory pathway optimization and acceleration strategy, global labelling (CCDS updates), marketing authorization applications (US, EU, China, Japan, Canada, and emerging markets-ROW), submission planning (eCTD), patient-focused development
Health Authority Meetings: Preparation support, briefing documents, rehearsals, meeting attendance, and health authority liaison
Quality system inspection: Strategy and inspection readiness
Submission support: Storyboarding/key messaging, core submission preparation and authoring, original application publishing with lifecycle maintenance, lifecycle publishing, global dossier management, RTQs, and CTA core dossier development
Stakeholder Management: Drug safety, technical operations, medical and commercial stakeholder management
Mergers and Acquisitions: Planning, submission authoring, dossier collection, and stakeholder management