Regulatory Manager
$106,000–$151,000 year
Remote
Job Summary
Provide regulatory development advice and guidance for optimal clinical trial conduct, ensuring timely preparation of quality regulatory submissions in compliance with applicable regulations. Coordinate and prepare documents for submission to Regulatory Authorities and Ethics Committees, including CTA/IND, annual reports, and marketing applications. Serve as a representative of Global Regulatory Affairs at project and business development meetings, leading projects regionally or globally as needed. Oversee Regulatory Affairs Specialists to achieve submission targets while maintaining project plans and trackers. Provide ICH GCP guidance and training to internal and external clients, and assist in developing company standards for submitted information quality. Keep abreast of evolving laws and guidelines governing drug development to support strategic regulatory input and timeline development.
Required Qualifications
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- Computer literacy (MS Office/ Office 365)
- Fluent in English
- 5 + years or more relevant regulatory affairs experience
- Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
- Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
- Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
- Availability for domestic and international travel including overnight stays
Desired Qualifications
- Graduate, postgraduate
- Possesses basic understanding of financial management
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