What are the responsibilities and job description for the Regulatory Specialist II & III position at Actalent?
Description:
- Responsible for assisting with the submission of research protocols and other required documents/components to the FDA for held investigational new drug (IND)/investigational device exemption (IDE) or biologics applications
- Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
- Assists with the technical review and report preparation and submission of FDA required reports of ongoing sponsored and held IND/IDE applications.
- Coordinates regulatory processes and submissions multi-site research.
- Assists Research Regulatory Manager in the orientation of new Research Regulatory Specialists.
- Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates (investigational brochures and/or device manuals) and ensuring completeness and accuracy of documents while meeting all applicable submission deadlines.
- Responsible for preparing and submitting new informed consent documents, revisions to the informed consent, including any required financial disclosure language, and communicating when IRB requires re-consenting of enrolled subjects. Also ensuring all languages of the informed consent requested by the study team are reviewed and approved.
- Ensure all regulatory documents, including all Essential Documents as defined by the ICH/GCP guidelines, are in compliance with all applicable Federal regulations, ICH/GCP guidelines, as well as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and all applicable AHRI policies and procedures.
- Monitors all required review, approval, and clearance activities for each research protocol maintaining detailed, complete, accurate and current records at the various stages of the process.
Qualifications:
- Bachelor’s degree in healthcare related field or biological sciences and at least 2 years work experience in a clinical research setting
- Associate Degree and at least 3 years work experience in a healthcare or scientific setting, with at least 2 years in a clinical research setting
- Equivalent work consisting of at least five (5) years of experience working in a healthcare or scientific setting, with at least 2 years in a clinical research setting including an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
