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.
Medical Device, Pharmaceuticals, Quality/Risk Management, Worldwide Regulatory Affairs
The Manager, Regulatory Consulting is a member of Life Sciences Consulting Services team; reporting directly to the Director, Clinical and Regulatory Consulting Services. The primary role of the Manager, Regulatory Consulting is to ensure all assinged work and work from the team is delivered on time, within cost and at the highest quality. Additional activities include working with the sales team to present our capabilities to new customers, build and defend proposals and RFPs, scope and price projects, team management and provide real-time employee feedback to further train the team to allow for growth opportunities. Lastly, working closely with the Manager, Regulatory Consulting EU and RoW to manage workload across the global team.
Business development (30%)
Provides responses to any received RFI and RFPs.
Holding scoping discussions with customers to ensure Clarivate have a robust understanding of a customer’s needs and requirements for any given project.
Working with Consulting services colleagues to provide robust effort estimates for scoped projects.
Drafting customer facing materials to support commercial discussions such as proposals.
Build a sustainable pipeline of services offerings and projects by identifying clients, understanding client requirements, and delivering unique solutions to each clients needs.
Communicates services offerings of the practice area, in RFP responses, and in support of individual opportunities to sales and to customers.
Develops case studies that describe practice area offerings and ensure those case studies are communicated and accessible.
Participates in opportunity development, to architect solutions and support the planning of Services projects from inception to contract closing.
Collaborates across Life Sciences to propose the highest value offerings to customers.
Regular pipeline review with PMO and Sales to ensure we have a clear vision of the pipeline.
Project Delivery Support (50%)
Become an integral member of the customer facing team of the Life Sciences Consulting Services team.
Act as the primary point of contact for the customer throughout a project’s lifecycle with responsibility for the service quality and deliverable quality of regulatory projects to customers.
Act as the project manager for regulatory consulting services to ensure successful delivery of each assigned project.
When required co-ordinate resources across the Life Science Consulting Services and Regulatory Intelligence teams to ensure the successful delivery of relevant projects.
Escalates any project risks and delivery issues to the Director / Global Practice Lead for action and resolution.
Support the delivery of non-regulatory Consulting services as required and agreed with both their direct and matrix managers.
Collaborates with the Life Sciences Consulting Services teams in architecting solutions to client needs by employing the Clarivate Analytics suite of databases, prior industry knowledge and insights gained from primary and secondary research.
When necessary coordinates across Life Science Practice Areas to support projects that require collaborations across skills and assets.
Escalates delivery issues to Director, Clinical and Regulatory Consulting to support measures to meet client needs.
Ensure projects management and reporting
Manages and coaches a team of regulatory solutions consultants and business application consultant to grow their regulatory and consultancy skills
Recruits and retain talents
Manages external workforce of contractors.
Conducts mid-year and annual employee reviews for direct reports
Qualification and Experience:
Master’s Degree (Preferred) in life sciences with at least 15 years’ experience in Pharmaceutical Regulatory Affairs/Regulatory Intelligence in a given territory (Europe, Asia, North America/Latin America).
At least 10-12 years’ experience as a managing consultant to pharmaceutical or medical device companies in regulatory intelligence.
Experience in supporting regulatory Consulting services from initial discussions to delivery.
Knowledge and skills:
Expert knowledge in key areas of responsibility e.g. operating systems, networking technologies, security standards
Expert knowledge of relevant markets
Excellent customer service skills
Strong problem management, troubleshooting and analytical skills
Demonstrated ability to work with and manage virtual teams to successfully deliver projects
Demonstrated ability to learn and understand internal systems and processes
Able to work well under pressure in a demanding environment
Independent worker with excellent time management and escalation skills
Experience with remote access tools and methods
Telecommuting is allowed.
Internal Number: MgrRegConsult1
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