Sr. Regulatory Affairs Specialist (MAA and CTA )

Qualifications:

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 3+ years).

Knowledge, Skills and 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

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.