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Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant

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 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.

The base compensation range for this role in the posted location is: $112,600 - $212,700.

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

**Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees.** In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

+ 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

**Important Notice:** Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.

Disclaimers

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Click the following link for more information on your rights as an Applicant in the United States.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

Ref. code: 384729

Posted on: Dec 29, 2025

Experience Level: Experienced Professionals

Contract Type: Permanent

Location:

New York, NY, US

Brand: Capgemini Invent

Professional Community: Strategy & Transformation

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.