Principal Reg Affairs Spec
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
We are currently seeking a Principal Regulatory Affairs Specialistto join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.
In this role you will be a pivotal team member withregulatory affairs responsibilities leading discussions and coordinating regulatory strategies both locally and globally on assigned (Phase 1 to 4) clinical trials studies and projects.
You will be part of a global team providing innovative solutions and global regulatory expertise to provide strategic regulatory intelligence and guidance.
You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.
You will act as a representative of the regulatory department with other departments supporting business development working on initiatives and contributing to quality improvement. You will also arrange lead and report on regulatory agency meetings as a local expert.
The following skills are required to be successful in this position:
Preparation assembly and review of local regulatory submissions to ANVISA related to the clinical development dossier and clinical trial applications for drugs biologics advanced therapies and devices
interacting with sponsors and internal teams
review and assess clinical trial regulatory documents
review and assess scientific literature
support the bidding team by sharing local regulatory intelligence
attend meetings with local associations and participate in initiatives to foster clinical trials in Brazil
Qualifications - External
What the role requires you to have:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job
Knowledge of the local and global clinical trials landscape
Knowledge Skills and Abilities:
Excellent English language (written and oral)communication skills as well as local language where applicable
Great attention to detail and quality as well as excellent editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Strong 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
Strong 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
Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
Solid analytical investigative and problem-solving skills
Required Experience:
Staff IC
Key Skills
About Company
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