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REGULATORY AFFAIRS ASSOCIATE DIRECTOR - US SOLUTIONS, REMOTE

Company: PPD
Location: Morrisville
Posted on: June 24, 2022

Job Description:

JOB DESCRIPTIONSummarized Purpose:Provides technical/project leadership globally, providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance for product development from preclinical through registration and product optimization. Provides updates to personnel as required on country/regional/global regulatory intelligence, strategic regulatory authority updates, and acts as advisers to other units within the department, as well as any local country regulatory authorities. Acts as liaison with internal and external clients in the provision and marketing of these services.Essential Functions:

  • Acts as a global lead in providing review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
  • Acts as lead subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects. Provides internal clients with up-to-date legislation and guidance as it becomes available.
  • Ensures quality performance for key/managed projects.
  • Manages project budgeting/forecasting functions.
  • Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
  • Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
  • Oversees matrix/project leadership, training and guidance to junior team members.
  • Ensures compliance with relevant organizational and department SOPs and WPDs.
  • Participates in and leads launch meetings, review meetings and project team meetings. Leads departmental initiatives/project teams.Job QualificationEducation and Experience:
    • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
    • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).
    • Direct experience with pre-approval submissions to the US FDA including INDs, DSUR, amendments, and others.
    • Experience with the duties of US Agent
    • Experience with electronic publishing systems and regulatory management systems
    • Experience meeting with regulatory authorities in official meetings
    • Experience preparing correspondence and responses to US FDAThe following experiences are highly desirable:
      • Experience with marketing submissions
      • Experience with post-approval submissions and life cycle management
      • Experience with vaccines
      • Writing experience for orphan drug, fast track and pediatric plan submissionsIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:
        • Mastery of English language (written and oral) communication skills as well as local language where applicable
        • Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
        • Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
        • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
        • Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
        • Professional negotiation skills
        • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
        • Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
        • Advanced understanding of medical terminology, statistical concepts, and guidelines
        • Outstanding analytical, investigative and problem-solving skills
        • Excellent understanding of budgeting and forecasting
        • Sharp executive presence and consultation and presentation skillsPPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
          • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
          • Able to work upright and stationary for typical working hours.
          • Ability to use and learn standard office equipment and technology with proficiency.
          • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
          • May require travel. (Recruiter will provide more details.)Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.COVID-19 Vaccination Update for U.S. Colleagues
            • All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
              • All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: PPD, Cary , REGULATORY AFFAIRS ASSOCIATE DIRECTOR - US SOLUTIONS, REMOTE, Executive , Morrisville, North Carolina

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