Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant

Capgemini•New York, NY

5d•Hybrid

About The Position

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. Your RoleAs a Senior Consultant, you’ll act as a trusted regulatory advisor for pharma and biotech clients, leading engagements on submission readiness (IND/NDA/BLA/MAA), regulatory strategy, eCTD compilation/automation, CDISC compliance, and inspection preparedness. You’ll pair deep regulatory expertise with business development to grow Capgemini’s regulatory service line, partnering closely with the Clinical Development practice and engaging directly with Regulatory VPs, CMOs, and Quality leaders.

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).

Nice To Haves

Former FDA/CDER/CBER reviewer experience.
VP/Director Regulatory experience in first-time submissions (IND → approval).
Background in specialized regulatory consultancies; Big 4 or boutique life sciences consulting.
Exposure to AI/ML devices, digital health, decentralized trials, RWE.
Strong network of regulatory VPs and quality leaders; published thought leadership or RAPS/DIA speaking.
Experience with international submissions (EMA, PMDA, Health Canada, other ICH regions).

Responsibilities

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).
Recruit regulatory and quality talent; mentor junior consultants on strategy, submissions, and compliance.
Deliver internal training on submission pathways, CDISC, eCTD, and inspection readiness.
Build a regulatory community of practice to share best practices and lessons learned.

Benefits

Hybrid working
We believe that flexibility is the key to a healthy work-life balance. That’s why our employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
Flex abroad
Capgemini’s Flex Abroad program gives employees the opportunity to work abroad for up to 45 days in a 12-month period. This allows you to temporarily change your working environment while staying connected to your team and career goals.
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