VP Regulatory Affairs

Company: Dohmen
Location: Palm Springs
Posted on: March 22, 2020

Job Description:

The most important aspect of the Regulatory Affairs Consulting Vice President is to be responsible for the Regulatory Affairs Consulting Service line (Pharmaceutical, Biologics, and Medical Devices). This position is a 50% billable, 40% business development and 10% leadership role. The Regulatory Affairs Consulting VP will be a Consulting Service Line Leader and ensure high quality consulting is provided to EVERSANA's clients specifically as it relates to regulatory affairs. The most important aspect of the position of the Regulatory Affairs Consulting VP will be having the responsibility for managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This person will function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. This position is a member of EVERSANA's Executive Management Team (EMT). This position is also a member of the Management Review Team.ResponsibilitiesESSENTIAL DUTIES AND RESPONSIBILITIES:Our employees are tasked with delivering excellent business results through the efforts of their teams.-- These results are achieved by:This leader will spend 50% of their time providing high level strategic quality consulting (billable) and 40% of their time conducting business development activities and 10% of their time managing the regulatory affairs consulting organization which includes employees and 1099 contract employeesManaging the regulatory aspects of projects, including complex applications submitted to various regulatory agenciesDevelopment of new customer projects that generate additional Regulatory work as well as developing existing customer relationships leading to additional revenue, profit and referralsEnsuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirementsParticipate in Regulatory speaking engagements as a way to actively rebrand EVERSANA and encourage additional market recognitionIn conjunction with the Operations SVP, the incumbent will set the EVERSANA Regulatory strategy and support the group to execute against the strategyDeveloping strategic regulatory approaches for projects, as appropriate with very limited oversightPreparing and writing complex submissions and other regulatory filings as requiredPlanning and conducting formal meetings and teleconferences with regulatory authoritiesAll other duties as assignedReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.PEOPLE LEADERPeople leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values.-- In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline and discharge and administer all other personnel actionsResponsible for and oversee their respective departmentInterview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and proceduresEnsuring that the training plans for his/her employees are developed and executedEXPECTATIONS OF THE JOB:Responsible to deliver business results and new business for the regulatory affairs consulting groupResponsible to guide and mentor staffResponsible to identify training and resource gaps to the appropriate EVERSANA managementTravel - Up to 25% required (may occasionally exceed 50%)Hours - Average 50 hours/weekThe above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.An individual in this position must be able to successfully perform the expectations listed above.QualificationsMINIMUM KNOWLEDGE, SKILLS AND ABILITIES:The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.Bachelor's degree in a related discipline with a minimum of 15 years regulatory affairs experience is preferred; 10 years of regulatory affairs experience is required in the pharmaceutical industry; medical device experience highly preferredA minimum of 10 years of FDA regulatory and quality systems experience is requiredIncumbent must be able to operate in a highly structured environment and manage multiple projects simultaneouslyAbility to work with and lead internal consulting employees within the regulatory affairs organization and external clients simultaneouslyAbility to bring on additional quality consulting resources to fulfill EVERSANA consulting business commitmentsAbility to manage multiple projects and deliverables in a timely fashionAbility to bring in new business, execute signed quality statements of work with high degree of service, and provide upsell opportunities to existing clientsInternal and external customer focusTimeliness in achieving deliverablesOrganizational skillsExcellent written and verbal communicationPREFERRED QUALIFICATIONS:Experience managing technical resources is highly desired

Keywords: Dohmen, Palm Springs , VP Regulatory Affairs, Executive , Palm Springs, California