Strategic Initiative Lead – Regulatory Data, Digital and AI

Role Summary

Strategic Initiative Lead – Regulatory Data, Digital and AI. Location: Cambridge, MA or Morristown, NJ. Lead initiatives at validation and acceleration stages of the innovation funnel, applying regulatory expertise to transform concepts into scalable, business-ready solutions within Global Regulatory Affairs (GRA).

Responsibilities

• Lead selected initiatives from incubation through validation and acceleration, designing success criteria, validation metrics, and learning agendas.
• Translate early concepts into tangible pilots, proofs of value, or minimum viable capabilities that can secure time and budget for scaling.
• Reframe business problems by leveraging regulatory SME expertise to ensure initiatives move from good to great.
• Represent initiatives with senior stakeholders, clearly communicating assumptions, progress, risks, and opportunities.
• Influence decision-makers with strong business cases built on regulatory insight, user needs, and measurable outcomes.
• Serve as a visible champion of innovation within GRA and with external partners.
• Partner with Innovation Leads, Capability Heads, and Digital teams to ensure smooth handoffs across the innovation funnel.
• Co-create with Innovation Leads, Capability Analysts, and Process Owners to refine problem statements, requirements, and adoption pathways.
• Connect with external partners, vendors, and regulators to stress-test ideas and anticipate future directions.
• Actively shape the Engagement & Innovation portfolio by screening, assessing, and prioritizing incoming demand.
• Contribute to the continuous improvement of the innovation funnel, ensuring scalability, compliance, and measurable value realization.
• Provide thought leadership on regulatory innovation trends, risks, and opportunities.

Qualifications

• 8+ years of experience in Regulatory Affairs or related area, with demonstrated impact in digital transformation, capability building, or strategic programs.
• Bachelors’ degree in Life Sciences, Pharmaceutical, Regulatory Affairs, Digital Health, or related field.
• Advanced degree (Masters, PhD) in Life Sciences, Pharmaceutical, Regulatory Affairs, Digital Health, or related field (preferred).
• Certifications in project management, innovation frameworks (Lean Startup, Strategyzer, Design Thinking, Strategic Foresight), or regulatory science (preferred).

Skills

• Regulatory Affairs Expertise: Deep understanding of regulatory information management, submissions, labeling, or lifecycle management.
• Program Leadership: Strong project/program management skills, with the ability to handle ambiguity and pivot quickly.
• Strategic Communication: Ability to simplify complex concepts and tailor messages to executives, SMEs, and cross-functional partners.
• Proven track record of managing complex, high-risk initiatives in global or matrixed pharma/biotech environments.
• Experience framing problems, validating assumptions, and building compelling investment cases.
• Interpersonal Influence: Ability to secure buy-in across diverse stakeholders, from end users to senior leaders.
• Growth Mindset: Comfortable with experimentation, uncertainty, and continuous learning.

Education

• Bachelors’ degree in Life Sciences, Pharmaceutical, Regulatory Affairs, Digital Health, or related field. (Required)
• Advanced degree preferred (Masters, PhD).

Additional Requirements

• Travel requirements not specified as essential.