Premier Research
Senior Regulatory Submissions Lead
United States of America · Senior · Contract
Sponsorship not specifiedDetected 7 hours ago
GCPBusiness DevelopmentExcelProcess ImprovementCustomer SupportClinical TrialsFDA RegulatoryResearchLeadershipMentoringPublic Speaking
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Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
- The annualized minimum base pay for this role is $145,000.00 USD.
- Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines.
Responsibilities
- Act as the primary regulatory & submissions lead for sponsors and project teams, ensuring alignment on timelines, deliverables, submission strategies, document readiness, and regulatory requirements.
- Proactively identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns; provide recommendations for resolution; and lead regulatory and submission-related discussions during kick-off meetings, and internal/external study calls.
- Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents such as application forms, cover letters, Patient Information Sheets/Informed Consent Forms (PIF/ICF); import/export applications; and country-specific submission packages.
- Review essential clinical and regulatory documents including IMPDs, protocols, Investigator's Brochures, master/country informed consent forms, investigational product labels, and other regulatory materials to ensure compliance, completeness, quality, and country-specific acceptability requirements.
- Drive start-up readiness by defining and agreeing Greenlight Package templates with sponsors, coordinating the completion of country and site greenlight packages with Study Start-Up Associates (SSUAs), and supporting overall country and site activation strategies in partnership with other functional areas to ensure efficient progression from regulatory approval to site activation.
- Maintain operational excellence, compliance, and financial oversight by ensuring high-quality execution of all regulatory and start-up activities, staying current with evolving regulations and guidance, supporting continuous process improvement initiatives, monitoring study start-up budgets and contractual obligations and identifying out-of-scope activities related to their functional area.
- 8-10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent
- Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable. Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug / device development, and start-up procedures.
- Excellent team player, collaborative and able to build an effective team.
- Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug / device development, and start-up procedures.
Compensation
- The annualized minimum base pay for this role is $145,000.00 USD.
- The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Benefits
- As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
- Education to university degree level (pharmacy, medicine or related natural sciences are a plus)
Company info
- What We Are Searching For:
- We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Visa & Work Authorization
- Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents such as application forms, cover letters, Patient Information Sheets/Infor
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This listing is sourced directly from Premier Research's careers page and normalized into a canonical job model.