LS Reg Affairs & Qlty - Sr Consultant

Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant

Join the Capgemini Invent team as a Senior Consultant in our Life Sciences Regulatory Arts & Quality practice. We drive transformation through strategic, creative and scientific capabilities, delivering cutting‑edge solutions to pharma and biotech clients.

As a trusted regulatory advisor, you’ll lead engagements on submission readiness (IND/NDA/BLA/MAA), regulatory strategy, eCTD compilation/automation, CDISC compliance, and inspection preparedness. You’ll partner closely with the Clinical Development practice and engage directly with Regulatory VPs, CMOs, and quality leaders to grow Capgemini’s regulatory service line.

• 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.

• 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, Master Control, LORENZ docu Bridge).

• 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.

• 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, Master Control, LORENZ docu Bridge; 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 (Pharm
  
  D/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).

• 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…