Regulatory Affairs Specialist

Posted:
12/23/2024, 1:12:39 AM

Location(s):
Ceará, Brazil ⋅ Brasília, Federal District, Brazil ⋅ State of Bahia, Brazil ⋅ Federal District, Brazil ⋅ State of São Paulo, Brazil ⋅ São Paulo, State of São Paulo, Brazil

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Legal & Compliance

Workplace Type:
Remote

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Alimentiv

Website: http://www.alimentiv.com/

Headquarter Location: London, Ontario, Canada

Employee Count: 251-500

Year Founded: 1986

IPO Status: Private

Industries: Biotechnology ⋅ Clinical Trials ⋅ Consulting ⋅ Health Care ⋅ Pharmaceutical ⋅ Precision Medicine

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