Pittsburgh, PA, United States
$60,000 - $90,000
about 1 year ago
Are you looking to develop and mould an entire Regulatory Affairs department in the way that you deem fit and most effective? Are you wanting to work for a start-up biotech whose product has completed the phase II clinical trial and will soon start phase III for a potentially revolutionary treatment?
Responsibilities of the Role
- Monitor and maintain familiarity with evolving and/or new regulatory e-submission requirements.
- Develop and maintain efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.Manage all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
- Collect, review and revise study reports and documentation to ensure high-quality preparation of applications in compliance with FDA and other global health authority requirements.Monitor and maintain the highest level of submission standards.
- Interact with regulatory agencies, coordinate the preparation of responses to questions and inquiries from FDA and other health authorities.
- Ensure relevant US and international regulatory laws, regulations and guidance, as well as internal policies and procedures are followed to ensure regulatory compliance is maintained.Serve as regulatory approver for changes to product, process, clinical trial, etc.
- Maintain records and documents for filing amendments and annual reports as necessary to Regulatory authorities
- Monitor and maintain all regulatory activities to ensure compliance with relevant regulatory requirements, including but not limited to, protocol and information amendments, clinical study reports (CSRs, annual reports and safety reports to support clinical development in the US, EU, Canada, and other countries as necessary.)
Education and Experience:
- Requires a Bachelor’s degree in life science or related discipline, Masters or PhD preferred.
- At least 3 years of regulatory affairs with experience associated with global submissions.
- Experience with the research and development of biologics/ medical devices is highly desirable.
- Experience working with CRO’s desired
- Experience with e-submissions desired.
- Working knowledge of global regulatory requirements and processes and filing experience (IND, CTA, NDA, BLA)
- Strong verbal and written communication skills are essential.
- Excellent organizational and analytical skills. Attention to detail is essential