Our Regulatory Affairs global team within PPD® clinical research services deliver regulatory science services, providing regulatory knowledge which accelerates innovation and improves regulatory decision making – and helps our customers deliver life-changing therapies to patients faster.

Discover Impactful Work:

Serves as a senior contact in providing innovative solutions including regulatory expertise, interacting with clients to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Key responsibilities:

• Prepares and reviews regulatory submissions.
• Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in implementing strategies.
• Leads the development and implementation of project-specific processes for sponsors.
• Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
• Assists in identifying and recognizing 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.
• Provides training and guidance to junior team members as appropriate.
• Participates in project launch meetings, review meetings and project team meetings.
• Supports business development activities, including project budgeting/forecasting.

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 5+ years).

Knowledge, Skills, Abilities

• Strong English language (written and oral) communication skills as well as local language where applicable
• Solid attention to detail and quality as well as strong editorial/proofreading skills
• Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Solid 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
• Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Solid understanding of medical terminology, statistical concepts, and guidelines
• Strong analytical, investigative and problem-solving skills
• Working knowledge of budgeting and forecasting