Pharmaceutical Product Development, The
Regulatory Affairs Specialist
Pharmacy or Life Science
The Regulatory Affairs Specialist provides regulatory advice and carries out 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. Interfaces with PPD project teams, sponsors, and FDA regarding regulatory strategy/submission activities.
Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects. Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities. Acts as primary liaison between Regulatory Affairs Department and project team for assigned protects.
Qualifications
Education and Experience:
Bachelor's Degree in Pharmacy or Life Science
2-3 years regulatory experience, or combination of higher education/less experience
Or substitution of equivalent relevant work experience
Knowledge, Skills and Abilities:
Broad regulatory affairs experience
Good interpersonal skills
Good knowledge Global Regulatory Affairs Procedures
Proven ability to work effectively in a team
A good knowledge of a number of country specific 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
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