Summary of The Position:
The Regulatory Affairs Associate will support the Regulatory Affairs leaders in the execution and coordination of all tasks associated with the regulatory aspects of clinical projects undertaken by the Company, in accordance with the relevant trial protocol and other trial-related documentation, ICH GCP, SA GCP (if applicable to geographical area), local regulatory and IEC requirements, local legal requirements and relevant international guidelines in other African countries, the USA (FDA), Europe (EMA), including applicable procedural documents.
- Planning and execution of regulatory matters pertaining to clinical trials.
- Act as the primary contact with the regulatory authority in South Africa (SAHPRA), Ethics Committees and any other authorities with jurisdiction over clinical trial authorisations, including the Trial Registries, NHREC, Provincial Authorities, Biosafety Directorate, Atomic Energy Board, etc., as applicable to specific trials.
- Similar functions apply to Regulatory Authorities in other countries, as applicable to specific trials.
- Collecting and collating of all documentation required for regulatory applications to conduct clinical trials.
- Providing training and support to staff on all regulatory matters.
- Perform a documented review of the applicable websites of all relevant Health Authorities and Ethics Committees and other applicable websites for relevant revisions of requirements, including but not limited to guidelines and forms, safety information and other aspects, related to clinical trials
- Review and preparation of documents for regulatory completeness, consistency, and accuracy, and interact with project team members to assure completeness, as necessary.
- Understand the Scope of Work and deliverables for any assigned project.
- Identify project needs, track timelines, and manage day-to-day workload in collaboration with the Regulatory Affairs Manager and/or Head of Regulatory Affairs.
- Provide administrative support and assistance to the Safety Team, the Regulatory Affairs leaders in the performance of duties as the primary point of contact for Pharmacovigilance for sponsors.
- Assist in ensuring serious adverse events and safety reports are submitted according to Company SOPs and sponsor specifications
- Perform other tasks or assignments, as delegated by the Regulatory Affairs leaders
- Follow Procedural Documents consistently; provide independent thought to assist in process improvements
Knowledge, Skills and Abilities:
- Effective oral and written communication skills in English
- Knowledge of other regional languages advantageous
- Excellent interpersonal skills
- Uncompromising attention to detail and the ability to think analytically
- Organization and planning ability
- Sound problem solving and decision-making skills
- Computer skills and the ability to learn appropriate software
- Medical/therapeutic area knowledge and medical terminology
- High level of interpersonal awareness and diplomacy
- Excellent knowledge and understanding of Research and Development process, international and local regulations, and guidelines applicable to clinical research
- The ability to work unsupervised / independently on several projects
- Education: Bachelor’s or higher graduate degree in a science-related field, licensed or certified health care training or equivalent experience.
- Preferred Job-related Experience: A minimum of three years of experience in a clinical research setting is preferred. Experience in the collection and collation of required documentation in support of regulatory and other applications would be a recommendation.
- Typical office environment.
- Ability to sit and stand for extended periods of time.
- Ability to lift or push 5-15 lbs / 2,27-6.8 kg.
- Expected travel time is less than 10% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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