Director, Regulatory Affairs Operations

Exceptional opportunity for an innovative Regulatory Operations leader to join the Parexel Team as a Director, Regulatory Affairs!

We are looking for a strategic and client focused regulatory professional who is seeking an opportunity to be part of transforming Regulatory Operations as we look to revitalize our portfolio of services and technologies. In this exciting role, the Director, Regulatory Affairs will use his/her project and submission management experience to lead a team of regulatory operations subject matter experts; provide senior level oversight to high revenue client engagements; work with experienced consultants to tailor client specific solutions; and continue to build and grow our service offerings.

Additional responsibilities:

Lead the Parexel and Client teams by combining deep regulatory experience with insight into client pressures in order to develop the right solution for the client. This requires developing in-depth project management skills and business understanding, knowledge, and experience in order to independently make effective decisions and take action.Provide oversight of large, complex or multi-year outsourcing programs and provides direction to project teams in order to achieve operational excellence, delivering projects/programs on time, to budget, to the highest quality, and that exceed client expectations. A Director may be billable during the transition period for new projects.Help develop new and innovative solutions through continued focus on thought leadership and aligning to ONE Parexel for end to end solutions. Support Client Relationship Directors and Consultative Sales Directors to drive account expansion in existing accounts and provides subject matter expertise leading to new account acquisition.Monitor and evaluate industry and competitor initiatives, changes in policy, and technology trends that impact the industry to ensure the highest standard of delivery to the client. This position is accountable for the profitability of a project(s) or program(s), the development of the client relationship, and client satisfaction. Staff Management

Actively manage performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses) Provide applicable guidance and support to staff in order for staff to succeed and achieve key metrics Support development plans for staff and coordinates with senior management to ensure that staff is utilized completely and appropriately to increase their expertise Advocate for staff to senior management in order to provide opportunities to expand staff skill sets Regularly communicates with staff to assure effective two-way information flow (i.e. business updates, project updates, staff interests, issues, and/or concerns)QualificationsQualified candidates will have:

At least 10 + years working within Regulatory Affairs/Operations to include experience managing a team. Previous experience managing remote staff is preferred, and experience managing global staff is a plusExtensive experience in Regulatory Operations including, submissions management, publishing and use of regulatory technologyA minimum of a Bachelor’s degree in a scientific or industry related program of studiesSignificant pharmaceutical industry or consultancy experienceProject Management ExperienceExtensive Regulatory operations and/or affairs experienceBusiness development experienceBudget managementProven substantial leadership and people management experience Proven track record of developing client relationships at program level 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.