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Director Global Regulatory Affairs

Work from home Full-time role Hiring

Worker Location Remote Job Description (include education requirements and years of experience needed) PhD/PharmD required. Must have 8+ years experience in industry. Experience at FDA a plus. Director, Global Regulatory Policy & Innovation (Contract) Role Summary This role serves as a strategic integrator within the US team of the Global Regulatory Policy and Innovation (GRPI) team, translating emerging external policy, regulatory, and scientific developments into actionable insights that shape R&D and portfolio decisions. The position is designed to move beyond monitoring activity to influencing how the organization anticipates and navigates change, partnering closely across R&D, Regulatory, and Public Affairs to drive aligned and informed decision-making.

Key Responsibilities

Interpret complex external policy and regulatory developments and translate them into clear implications for product and pipeline strategy and enterprise priorities Influence decision-making across cross-functional stakeholders without formal authority, enabling faster, more cohesive strategic choices Partner with Regulatory, R&D, and Public Affairs to ensure a shared, aligned understanding of the external environment and its implications Identify weak signals and emerging trends, distinguishing signal from noise to proactively shape internal strategy Enable product teams by providing targeted, high-impact input Build and leverage internal and external networks to advance clients thinking and position on key regulatory policy topics Capabilities and Profile Deep expertise in regulatory policy, regulatory science, and R&D strategy in a complex biopharma environment Demonstrated ability to influence senior stakeholders and shape decisions without direct ownership Strong integrative thinking able to connect science, policy, and business strategy into actionable recommendations Excellent executive communication skills, with the ability to distill complexity into clear, decision-relevant insights High learning agility, sound judgment, and comfort operating in ambiguity Target Start and End Date ASAP to September 30 Cost Center o If CapEx/OpEx, please also include IO task codes, GL codes, etc. Copying Dylan to see if he can help. Work Arrangement (hybrid, remote, onsite please specify # of onsite days per week) Remote Remote Skills: Business Strategy, Communication Skills, Cross-Functional, FDA (Food and Drug Administration), Product Strategy, Public Affairs, Regulations, Research & Development (R&D), Trend Analysis About the Company: Lancesoft We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status. Company Size: 2,000 to 2,499 employees Industry: Staffing/Employment Agencies Founded: 2000 Website: http://www.lancesoft.com/

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