GSK

Sr. Director – Biopharm CMC Strategy, Policy and Advocacy

GSK

full-time

Posted on:

Location Type: Office

Location: Washington D.C. • Washington • United States

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Salary

💰 $193,500 - $322,500 per year

Job Level

Senior

About the role

  • Develop and implement CMC regulatory strategies to influence CMC policies and guidelines, with a focus on the US
  • Engage with regulatory agencies, industry groups, and other stakeholders to advocate for a CMC regulatory environment enabling innovation and patient access
  • Monitor and analyze CMC trends, providing strategic CMC regulatory insights to internal teams
  • Lead cross-functional business teams to ensure compliance with global CMC regulatory requirements and implement innovative CMC strategies
  • Represent the company in industry forums, conferences, and regulatory meetings
  • Collaborate with internal departments to align CMC regulatory strategies with business objectives and delivery of the innovative medicines pipeline

Requirements

  • Advanced degree in a scientific discipline (Ph.D., Pharm.D., or equivalent preferred)
  • Minimum of 10 (12+ for Sr Director) years of experience of CMC within the biopharmaceutical industry
  • Strong knowledge of global CMC regulatory requirements and guidelines
  • Excellent communication, negotiation, and advocacy skills
  • Proven ability to build and maintain relationships with regulatory authorities and industry stakeholders
  • Experience of developing a policy and intelligence network, with a focus on the US
  • Strategic thinker with the ability to influence and drive CMC regulatory policy changes
Benefits
  • health care and other insurance benefits (for employee and family)
  • retirement benefits
  • paid holidays
  • vacation
  • paid caregiver/parental and medical leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC regulatory strategiesCMC policiesCMC regulatory requirementsregulatory insightspolicy developmentregulatory compliancebiopharmaceutical industry experiencestrategic CMC regulatory planningtrend analysisinnovative CMC strategies
Soft Skills
communication skillsnegotiation skillsadvocacy skillsrelationship buildingstrategic thinkinginfluencing skillscollaborationleadershipcross-functional team managementstakeholder engagement
Certifications
Ph.D.Pharm.D.