PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
The Global Regulatory Affairs Services department provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.
As an Associate Director, Regulatory Affairs you will provide 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.
This position offers continued career advancement working from an office or from home within the Global Regulatory Affairs Services department or other departments within PPD.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.
Summarized Purpose:May manage a large, regional and/or global team of staff and managers within the department and provides 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:
- May manage 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.
- Manages 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.
- Contributes to development and implementation of global/regional function/plans.
- Ensures compliance with relevant organizational and department SOPs and WPDs
- Creates 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:
- 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 10+ years).
- 5+ years of management responsibility preferred
- Proven leadership skills
- Experience with New Drug Applications and Biologic License Application Approvals preferred
Knowledge, Skills and Abilities:
- Effective English language communication and negotiation skills, as well as local language where applicable, both oral and written
- In-depth understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management
- Broad understanding of ICH and other global regulatory guidelines Advanced knowledge of at least one of the regulatory speciality 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
- Capable of delegating tasks and facilitating the completion of assignments
- Capable of driving innovation in developing new ideas related to process improvements
- Comprehensive 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