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CANDIDATES CAN BE BASED OUT OF THE NEW YORK METRO, CHICAGO, OR SAN FRANCISCO.

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 Life Sciences / Pharma clients' challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.

The Life Sciences industry is undergoing dramatic changes, impacted by patent expirations, patient empowerment, increased regulatory scrutiny, and stringent cost containment. While the industry continues to lower costs and consolidate, it is seeking new growth opportunities through innovation, diversification, and expansion in emerging markets. Capgemini Invent’s Life Sciences practice has partnered with leading pharmaceutical and biotechnology clients to help define and deliver their future state for more than 25 years. The dedicated team guides clients from strategy to execution across the value chain. The practice’s core focus areas are **commercial and digital transformation, innovation, business agility, patient services, and patient experience** .

Skilled across the product lifecycle, the team brings deep experience in early commercialization, product launch, brand growth, and lifecycle management. The team’s consultants help drive change and transform organizations. Leaders in digital transformation, the team has helped clients establish innovation incubators, develop digital medicine strategies, enhance patient experiences, and identify new revenue sources.

YOUR ROLE

Scope & Responsibilities

As a Senior / Managing 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.

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?

You’ll have the opportunity to:

+ Build a network within the Capgemini Group and contribute to the education of other Business Units around Life Sciences practice offerings to support existing account expansion

+ Play a significant role in client proposals and RFI/RFP responses from initial brief to final sales presentations

+ Nurture and expand existing account relationships

+ Identify potential personal business relationships that can be leveraged by the practice to develop new business

+ Identify potential project extension and expansion opportunities while staffed on projects

+ Support the development of thought leadership and innovative offerings as they relate to AI/Data Science, Digital Customer Analytics, and Operational Analytics.

+ Support the upskilling of the Life Sciences team members on topics related to Data & Analytics

_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._

_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 accommodations do not pose an undue hardship._

_Click the following link for more information on your rights as an Applicant:_ _http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law_

ABOUT CAPGEMINI

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, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.

Job:

**Organization:** _INVENT PEOPLE S&T_

**Title:** _Capgemini Invent – Senior / Managing Consultant – Life Sciences, Regulatory Affairs & Quality_

**Location:** _NY-New York_

**Requisition ID:** _082757_

**Other Locations:** _US-IL-Chicago, US-CA-San Francisco_