Regulatory Affairs Manager - Chemistry, Manufacturing and Controls ( CMC )
Regulatory Affairs Manager - Chemistry, Manufacturing and Controls (CMC) - Home or Office Based - 145062
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 a Regulatory Affairs Manager (CMC) you will provide regulatory advice and support on strategy, plus manage and provide input into projects in the provision of regulatory affairs CMC services.
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: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 internal and external clients in the provision and marketing of these services. *LI-JN1
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 9+ years).
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: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 a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
Superb understanding of medical terminology, statistical concepts, and guidelines
Excellent analytical, investigative and problem-solving skills
Excellent understanding of budgeting and forecasting
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.