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Senior Regulatory Affairs Specialist Full-time

de PPD em São Paulo (Publicado em 09-11-2018)

Senior Regulatory Affairs Specialist - 151654

Description

This position provides regulatory advice and assists in management of projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature.

Qualifications
Education and Experience:

  • Bachelor's degree in Pharmacy or Life Science

  • 3-5 years regulatory experience or combination of higher education/less experience

  • Substitution of equivalent relevant experience for degree is allowed

Knowledge, Skills and Abilities:

  • Broad regulatory affairs experience

  • Good interpersonal skills are essential

  • Good knowledge of Global Regulatory Affairs Procedures

  • Proven ability to work effectively in a team

  • A good knowledge of a number of country clinical trial application procedures

  • Expert knowledge of ICH and global regulatory guidelines

  • Familiar with computers and their applications

  • Good organizational and planning skills

  • Must be able to work autonomously with minimal supervision

  • Planning skills

  • Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking

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, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.


Organization
- Regulatory Affairs

Primary Location
- Latin America-Brazil-Sao Paulo-Sao Paulo


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