Técnico de Regulatory Affairs
Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects.
- Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes involved in a small single service project, under the guidance of senior staff.
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
- Understands the Scope of Work, deliverables and management of budget for any given project.
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and present to clients at bid defence meetings by phone or in person.
- May prepare and deliver training, as appropriate.
- Performs other tasks or assignments, as delegated by Regulatory management.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate
- Good, solid interpersonal communication (oral and written) and organisation skills
- Strong software and computer skills, including MS Office applications
- Demonstrates self-motivation and enthusiasm
- Ability to work on several projects, with direction from senior staff as appropriate
- Ability to follow SOPs consistently; provides independent thought to assist in process improvements
- Ability to make decisions on discrete tasks under senior supervision
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent plus at least 1 year relevant experience* or high school diploma plus at least 5-7 years experience* (*or combination of education, training and experience).
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