Your Role

As 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.

Key Focus Areas

Regulatory Submissions & Strategy: IND/NDA/BLA/MAA pathways (traditional, 505(b)(2), accelerated, breakthrough).
eCTD & CTD Readiness: Compilation, validation, automation; CTD Modules 2?5 gap remediation.
CDISC Compliance: SDTM, ADaM, Define.xml (with SEND awareness) and dataset remediation.
Inspection Preparedness: FDA/EMA mock inspections, audit readiness, corrective/preventive actions.
Health Authority Engagement: Briefing docs, risk mitigation, ESG/EMA gateway submission processes.

Project Delivery

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.

Business Development

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.

Building Our Brand

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).

People Development

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.

Qualifications & Experience

Skills & Experience (Required)

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).

Preferred

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).

What You'll Love About Working Here

At Capgemini Invent, we empower our people to explore, innovate, and progress. As a global community of entrepreneurial thinkers, you?ll be encouraged to step up, try new things, and make a mark. As part of Capgemini Invent, you?ll have the flexibility to work your own way and find your balance. We give you the ownership and support you need to grow your skills and shape your future path.

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.