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 & Tools

regulatory affairsIND submissionsNDA submissionsBLA submissionsMAA submissionseCTDCDISCdataset remediationrisk assessmentproject planning

Soft Skills

consultingstakeholder managementexecutive communicationleadershipstrategic thinkingindependencebusiness developmentcross-functional collaborationpresentation skillsthought leadership

Certifications

RACPharmDPhDMSMD