Sr Reg Affairs Spec

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized Purpose:

Serves as the lead over several countries/projects in providing innovative solutions including regulatory 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.

• Work closely with PPD site intelligence and activation and the clinical management team to provide an efficient and integrated service for the PPD regulatory 'green-light' process to authorize the initial investigational product shipment to a site and/or site activation.
• Review and approve essential documents for compliance with GCP regulations and guidance, in addition to any applicable local/national regulations that meet review criteria.

Verify the following essential documents globally:

• Principal Investigator's CV.
• Ethics committee approval documentation.
• Ethics committee approved ICF(s).
• Regulatory authority approval documentation.
• Protocol signature page(s).
• Form FDA 1572/Clinical Studies Information Form (CIF).
• Financial disclosure forms for principal investigator listed on US FDA form 1572/CIF.
• Other country specific essential documents, as required.

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 8+ years).

Knowledge, Skills and Abilities:
Excellent English language (written and oral) communication skills as well as local language where applicable
Great attention to detail and quality as well as excellent editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Strong 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
Strong 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
Strong 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; good understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, Publishing etc