Director of Regulatory Affairs - Customer Dedicated (FSP) co

at PPD in Nuremberg, United States

Job Description

*Various Seniority Levels
*Home-Based/Remote Based Contract Opportunity
*Full Time (FTE 1.0)
*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?
Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team.
Functional Service Partnership Homepage:

Position Summary
Provides operational leadership for the department, overseeing 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. Manages projects and participates in strategic initiatives. Acts as liaison with internal and external clients in the provision and marketing of regulatory services.

Essential Functions

  • Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
  • Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products. Provides project specific strategy, technical expertise and coordination oversight for key client’s projects. Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
  • Oversees project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Leads and participates in project meetings.
  • Ensures identification of out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification.
  • Collaborates with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD. Actively engages in business development activities looking to attract collaborative and stand-alone projects. Pursues existing clients who have a need for services to win more business.
  • Contributes to development and implementation of global/regional function/plans.
  • Ensures compliance with relevant organizational and department SOPs and WPDs
  • Develops strategy and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team.
  • Participates in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics and other key performance indicators.
    Education and Experience Required
  • 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). 5 years of management responsibility Strong leadership skills
  • In 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

  • Superior English language communication and negotiation skills, as well as local language where applicable, both oral and written
  • Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC, publishing, etc.
  • Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
  • Capable of supervising, evaluating, and mentoring departmental personnel, as well as delegating tasks and facilitating the completion of assignments
  • Capable of driving innovation in developing new ideas related to process improvements
  • Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
  • Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
  • Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
  • Capable of independently learning new technologies
  • Capable of effectively acting as a liaison with other departments
    PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being 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.)

Job: Regulatory Affairs

Organization: PPD

Title: Director of Regulatory Affairs – Customer Dedicated (FSP) contract opportunity

Location: GB-GBR

Requisition ID: 169546

Other Locations: IE-IE-Dublin, DE-Germany, IT-IT-VERONA-FSP VERONA IT FSP Fleming, BG-BG-Sofia, DE-DE-Munich-FSP Munich DE Prince Regent Sq, DE-DE-Nuremberg, ES-ES-Madrid-FSP Madrid ES Plaza de Carlos, BG-BG-Sofia-FSP Sofia BG Tsarigradsko Shos, DE-DE-Munich, IE-IE-Dublin-FSP DUBLIN IE Rathfarnham, BG-BG-Sofia-Sofia 115G Tsarigradsko Shosse, DE-DE-Karlsruhe, ES-Spain, IT-IT-VERONA, GB-GB-Middlesex-FSP Uxbridge UK Stockley Prk W, ES-ES-Madrid-Madrid ES – Titan, 15, IT-IT-Segrate (MI), IT-IT-Segrate (MI)-Milano IT Via San Bovio, FR-France, IE-Ireland, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, ES-ES-Madrid, BG-Bulgaria, DE-DE-Munich-Munchen DE Hansastrasse, BE-BE-Rixensart-Rixensart FSP, BE-BE-Brussels-Brussels BE St Stevens Woluwe, BE-BE-Wavre-FSP Wavre BG Avenue Pascal, IE-IE-Athlone, IT-Italy, FR-FR-Ivry-sur-Seine Ced, BE-BE-Rixensart, GB-GB-Stevenage, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, FR-FR-France-FSP MarlyleRoi FR Versaille Rd, GB-GB-Cambridge-Cambridge GB Granta Park1, GB-GB-Bellshill, GB-GB-Cambridge, BE-BE-Brussels, BE-BE-Zaventem-Zaventem BE Cluster Pk

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without reg

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Job Posting: JC158650177

Posted On: May 09, 2020

Updated On: Sep 20, 2021