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Director Global Regulatory Affairs

Key Facts

Remote From: 
Full time
Senior (5-10 years)
English

Other Skills

  • Integrative Thinking
  • Decision Making
  • Learning Agility
  • Dealing With Ambiguity

Roles & Responsibilities

  • PhD/PharmD required
  • 8 plus years experience in industry
  • Experience at FDA a plus
  • Deep expertise in regulatory policy

Requirements:

  • Interpret complex external policy and regulatory developments and translate them into clear implications for product and pipeline strategy
  • Influence decision-making across cross-functional stakeholders without formal authority
  • Partner with Regulatory, RD, and Public Affairs to ensure a shared understanding of the external environment
  • Identify weak signals and emerging trends to proactively shape internal strategy

Job description

· 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

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