Sr Reg Affairs Specialist

hace 3 semanas

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

Summarized Purpose:
Serves as a senior contact in providing innovative solutions including regulatory expertise, interacting
with clients 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.
Essential Functions and Other Job Information:
Essential
Functions
Prepares and reviews regulatory submissions.
Provides regulatory strategy and/or technical advice to internal and external
clients, and acts as a liaison in executing strategies.
Leads the development and implementation of project-specific processes for
sponsors.
Collaborates extensively with other departments, regulatory consultants, and
regulatory authorities.
Assists in identifying and recognizing out of scope activities in a contract in a
timely manner and liaises with other departments to follow through on all
aspects of contract modifications.
Provides training and guidance to junior team members as appropriate.
Participates in project launch meetings, review meetings and project team
meetings.
Supports business development activities, including project
budgeting/forecasting.
Job Complexity Works on problems of diverse scope where analysis of data requires evaluation of
identifiable factors.
Job Knowledge A seasoned, experienced professional with a full understanding of area of
specialization; resolves a wide range of issues in creative ways. This job is the fully
qualified, career-oriented, journey-level position.
Supervision
Received
Normally receives little instruction on day-to-day work, general instructions on new
assignments. Demonstrates good judgment in selecting methods and techniques for
obtaining solutions.
Business
Relationships
Represents the department as a prime contact on projects. Interacts with internal
and external personnel on significant matters often requiring coordination between
functional areas. Networks with senior internal and external personnel in own area
of expertise.
Qualifications:
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
5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
Strong English language (written and oral) communication skills as well as local language where
applicable
Solid attention to detail and quality as well as strong editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other
departments
Solid 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
Solid 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
Solid understanding of global/regional/national country requirements/regulatory affairs procedures
for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other
global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical,
clinical, CMC, publishing, etc.
Solid understanding of medical terminology, statistical concepts, and guidelines
Strong analytical, investigative and problem-solving skills
Working knowledge of budgeting and forecastin

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