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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in product management and leadership, particularly in delivering AI and data-driven products within regulated environments. Possesses strong strategic oversight capabilities, stakeholder management skills, and a deep understanding of CMC regulatory frameworks and digital transformation.
Highest-signal resume keywords
Product ManagementAI/ML Product DeliveryRegulatory AffairsStakeholder ManagementTeam Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ScienceComputer ScienceAI Product DevelopmentGxP Computerised System ValidationNLG TechnologiesLLM TechnologiesAgile MethodologiesDigital ToolingAutomationTechnical Accountability
Soft Skills
Strategic OversightEvidence-Based Decision MakingOrganizational DesignCollaborationCommunication
Tools & Technologies
Electronic Quality Management SystemsDocument Management SystemsVQDAI ToolsDigital Platforms
Industry Keywords
CMCRegulatory ComplianceECTD Module 3ICH GuidelinesFDA GuidanceEMA GuidanceHealthcarePharmaceuticalsProduction TechnologyData Privacy
About the role
Key responsibilities & impact- Provide strategic oversight and long-range planning for the CMC report transformation product portfolio
- Define and own the product roadmap, sequencing investment and delivery to maximise scientific and business value
- Lead enterprise-level prioritisation across competing demands and make evidence-based trade-offs
- Hold end-to-end technical accountability for report transformation strategy and products
- Ensure solutions are architecturally sound, performant, validated, and fit for regulated CMC use
- Own people, budget, and delivery resources, including senior recruitment and organisational design decisions
- Lead stakeholder management across scientific, technical, quality, and senior leadership communities
- Build alignment and secure sponsorship for agentic AI initiatives
- Determine, measure, and articulate the value and impact of report transformation products
- Manage stakeholders across DDS, Regulatory, Digital & Tech, and Quality organisations
- Build, lead, and develop a high-performing product and technical leadership team
- Act as senior executive sponsor for report transformation within CMC
- Represent the function at VP and senior leadership forums and shape enterprise-wide digital and AI strategy
Requirements
What you’ll need- Bachelor's degree in Computer Science, Data Science, Engineering, Life Sciences, Regulatory Affairs, or a closely related scientific or technical field
- Experience in product management and product leadership, delivering data, software, and AI/ML products
- Experience operating at director level or above
- Substantial experience setting enterprise strategy for and delivering complex, production-grade AI products
- Experience with agentic or autonomous AI within a scientific, healthcare, or pharmaceutical (CMC) environment
- Direct experience transforming regulatory or technical report writing and documentation processes through automation, digital tooling, or AI
- Working knowledge of GxP computerised system validation principles, such as GAMP 5
- Familiarity with CMC regulatory report types and submission formats, including eCTD Module 3 structure
- Practical knowledge of NLG, LLM, and structured/templated authoring technologies
- Familiarity with ICH, FDA, and EMA guidance on automation and AI in regulated content
- Experience with electronic quality and document management systems, such as VQD
- Working knowledge of data privacy, information security, and intellectual property considerations for AI tools in life sciences
- Experience holding technical accountability for production technology products
- Experience evaluating, integrating, and governing third-party AI/data platforms and partnerships
- Understanding of the CMC development and manufacturing lifecycle
- Familiarity with agile and product delivery methodologies, such as Scrum and SAFe
- Demonstrated success building, leading, and developing high-performing teams and senior talent within a large, matrixed global organisation
Benefits
Comp & perks- Annual bonus may be offered
- Eligibility to participate in a share based long term incentive program
- Hybrid working model with a mix of on-site and remote work
- Agile working culture and flexibility opportunities
- Recruitment process adjustments available for applicants who require them