Senior Consultant, LS Reg Affairs & Qlty
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Office
Location: New York City • New York • 🇺🇸 United States
Visit company websiteSalary
💰 $112,600 - $212,700 per year
Job Level
Senior
Tech Stack
Google Cloud PlatformVault
About the role
- As a Senior Consultant, act as a trusted regulatory advisor for pharma and biotech clients
- Lead engagements on submission readiness (IND/NDA/BLA/MAA), regulatory strategy, eCTD compilation/automation, CDISC compliance, and inspection preparedness
- Pair deep regulatory expertise with business development to grow Capgemini’s regulatory service line
- Partner closely with the Clinical Development practice and engage directly with Regulatory VPs, CMOs, and Quality leaders
- Lead regulatory consulting programs: readiness assessments, strategy development, eCTD workflows
- Serve as the regulatory authority in client meetings; translate complex requirements into actionable plans
- Review CSRs, ISE/ISS, dossiers, and briefing packages with strategic input for FDA/EMA interactions
- Run CDISC validation (e.g., Pinnacle 21) and drive remediation to ensure submission-ready datasets
- Coordinate cross-functional teams (Clinical Ops, Biostats, Medical Writing, CMC, Nonclinical) to align timelines and deliverables
- Present risk assessments and recommendations to executive stakeholders
- Build and own the regulatory service line: prospecting, qualification, proposals, and commercial negotiations
- Lead regulatory sales cycles (discovery → contract); write technical proposal sections and timelines
- Contribute regulatory expertise to integrated Clinical Development proposals and cross-sell into existing accounts
- Represent Capgemini at RAPS, DIA (Regulatory tracks) to elevate brand and generate leads
- Develop innovative offerings: regulatory intelligence, eCTD automation accelerators, CDISC toolkits, AI-powered document review
- Publish thought leadership (white papers, webinars) on digital health guidance, AI/ML devices, and timeline optimization
- Forge strategic partnerships with regulatory tech vendors (Veeva Vault RIM, MasterControl, LORENZ docuBridge)
Requirements
- 12+ years in regulatory affairs; direct leadership of IND/NDA/BLA/MAA submissions (10+ successful filings)
- Expertise in eCTD, CTD Modules 2–5, FDA guidance, and health authority expectations
- Proficiency with CDISC (SDTM, ADaM, Define.xml; SEND awareness) and dataset remediation
- Hands-on with regulatory systems: Veeva Vault RIM, MasterControl, LORENZ docuBridge; ESG/EMA gateway tools
- Knowledge of GCP, 21 CFR Part 11, and data integrity
- Experience across emerging biotechs and large pharma portfolios
- RAC preferred; advanced degree (PharmD/PhD/MS/MD)
- Strong consulting toolkit: regulatory strategy, risk assessment, stakeholder management, project planning, executive communication
- Demonstrated independence leading end-to-end regulatory engagements and closing consulting contracts
- Mastery of Microsoft Office and planning tools (e.g., MS Project/Gantt); U.S. work authorization (no sponsorship)
Benefits
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade
- Company paid holidays
- Personal Days
- Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsIND submissionsNDA submissionsBLA submissionsMAA submissionseCTDCDISCdataset remediationrisk assessmentproject planning
Soft skills
consultingstakeholder managementexecutive communicationleadershipstrategic thinkingindependencebusiness developmentcross-functional collaborationpresentation skillsthought leadership
Certifications
RACPharmDPhDMSMD