Regulatory Affairs Manager - Medical Devices/Diagnostics/Rx - Home or OfficeBased - 146275
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 department provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.
As a Manager, Regulatory Affairs you will provide regulatory advice and support on strategy, plus manage and provide input into projects in the provision of regulatory affairs services for both medical device and diagnostics (MDD) and pharmaceutical projects.
This position offers continued career advancement working from an office or from home within the Global Regulatory Affairs 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.
Provides technical/project leadership over a region(s), providing innovative solutions including regulatory affairs expertise and client interface 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 internaland external clients in the provision and marketing of these services.
- Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
- Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. 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.
- Provides matrix/project leadership, training and guidance to junior team members.
- Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
- Participates in launch meetings, review meetings and project team meetings.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience with both MDD and pharma that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years).
Knowledge, Skills and Abilities:
- Excellent English language (written and oral) communication skills as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional 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
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Excellent 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
- Excellent 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; advanced understanding of MDD as well as drug regulatory requirements
- Superb understanding of medical terminology, statistical concepts, and guidelines
- Excellent analytical, investigative and problem-solving skills
- Excellent understanding of budgeting and forecasting
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, maritalstatus, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.