Principal Regulatory Affairs Consultant - CMC Biologics / Vaccines
Parexel International Corporation
USA - Any Region - Home Based
Parexel's Regulatory Consulting Services team continues to grow! We are currently looking for experienced CMC Biologics / Vaccines Regulatory Affairs professionals who are dedicated to Public Health, passionate about drug development, and committed to making a difference!
This is truly a fantastic opportunity to join Parexel’s highly recognized Regulatory Consulting Services Team as a Principal Consultant and work alongside some of the most respected Thought Leaders in the Industry!
As a member of Parexel’s Regulatory Consulting Services Team you will be working with a Team of highly experienced professionals with both Industry and FDA experience; you will have the opportunity to work with a variety of clients and products; you will have the opportunity to find solutions and execute on behalf of our clients; you will have the support of a dedicated Team of Business Development Professionals; and you will have the opportunity to continue to advance professionally and stretch your own thinking.
A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. Must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services PC provides. Provides a full range of consulting services and works within their personal area of expertise. Provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within Regulatory Consulting.
Project ExecutionWorks within a team environment or individually based on the project needs. Works within broad project guidelines and facilitates issue and conflict resolutions.Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope and objectivesCapitalizes on opportunities to improve project efficiency, results or team performance and proactively takes actionLeverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisionsProduces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met. Manages project engagements (small or large)Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project supportProvides guidance to project team members and acts as a mentor to junior staffThought LeadershipDelivers presentations at seminars and industry group meetingsAuthors articles for publication in industry magazines, newsletters, book chapters and other forumsMay 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 expertiseDrives knowledge-centered activities within PC as well as contributes to Parexel business process improvements.May contribute to new service and consulting model developmentQualificationsConsulting Activities and Relationship Management and Business DevelopmentApplies the appropriate organization’s consulting models and methodologies and assists in the design/improvement the methodologies when neededProvides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agenciesCompletes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfactionMay 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 clientFacilitates 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 activitiesDevelops business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry driversDemonstrated ability to interact professionally at multiple levels including senior and executive management within a client organizationPlans and delivers services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referralsIdentifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account managementActively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management. Presents information about PC service offerings reflecting the organization’s capability to support client needsGenerates new or repeat business due to personal name recognition or history of client satisfaction and/or relationshipLeverages 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 clientsParticipates 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 clientsEducation - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree MD preferred.
Language Skills - At least fluent vocal and written English
Minimum Work Experience - 15+ years’ CMC Biologics and/or Vaccines subject matter expertise/experience within the pharmaceutical industry or regulatory knowledge with a regulatory agency (such as FDA, MHRA) is required.
30% Domestic/International Travel Required
Now is the time to join this DYNAMIC Team and work alongside like-minded colleagues with a wealth of technical expertise from both Industry and the FDA!
EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.