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Regulatory Affairs Manager
at Piper Companies New York in New York (Published at 27-08-2022)
Piper Clinical is seeking a Regulatory Affairs Manager to join a global CRO in a fully remote capacity! The role prioritizes project management and is a permanent, direct placement opportunity.
Responsibilities for the Regulatory Affairs Manager include:
- Supporting and managing client portfolios for Sponsors
- Collaborating with cross-functional teams (such as Regulatory Writing, Regulatory Submissions, etc.) to execute projects and programs for Sponsors
- Coordinating project start-up activities, track and report project status, maintain project documentation, submission timelines, and scopes of work
- Serving as the primary point of contact for Sponsors and other regulatory personnel, ensuring client project needs are clearly communicated and promptly addressed
- Maintaining project timelines with multiple regulatory submissions
- Scheduling and leading internal & external project team meetings, preparing presentations, and developing meeting agendas
- Reporting project metrics and performing project close-out activities
- Attending clinical operations internal meetings as the representative for Regulatory Affairs
Qualifications for the Regulatory Affairs Manager include:
- 5+ years of regulatory experience within a CRO or pharmaceutical company
- Prior experience drafting and submitting reports for IND review is required
- Bachelor?s degree in Life Sciences or similar field is required
Compensation for the Regulatory Affairs Manager includes:
- Salary Range: approximately $120,000 - $180,000 annually, commensurate with experience
- Full Benefits: Medical, Dental, 401k, Flex PTO, Equity, Stock Options
Keywords
Regulatory affairs, reg affairs, reg specialist, regulatory specialist, reg manager, regulatory manager, pharma, pharmaceutical, biopharma, cro, clinical research, clinical research organization, ind, investigational new drug, clinical trial, phase i-iv, oncology, endocrinology, cardiology, metabolic disease, cns, central nervous system, regulatory submissions, reg submissions, irb, fda, new drug, clinical drug, drug product, global cro, medical device, med device, project manager, project management, pm, drug development
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