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CMC Regulatory Strategist

2 months, 2 weeks ago
United States
Full-time
Lead
Project Manager
Project and Program Management
Apply Now
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984
View All Jobs 14

Description

  • Provide strategic and tactical CMC leadership to clients and project teams across integrated development programs.
  • Review technical documents and support CMC and related regulatory components of development programs.
  • Collaborate with CDMOs, external vendors, and other partners on CMC-related activities.
  • Mentor and advise Rho staff on CMC regulatory strategy and product development.
  • Identify program risks, analyze issues, and develop contingency plans.
  • Track progress of key CMC deliverables against product development plan goals.
  • Communicate key issues, progress, and risks to project teams and senior management.
  • Support the planning, preparation, and conduct of regulatory authority meetings and lead CMC discussions.
  • Manage scope of work, budgets, and timelines for external vendors, consultants, and CMC writers.
  • Participate in business development activities, including opportunity assessment, conferences, capture activities, and proposal support.

Requirements

  • PhD, PharmD, or equivalent demonstration of analytical ability.
  • Minimum of 12 years of experience in development programs with inter-related clinical, nonclinical, CMC, and regulatory experience.
  • FDA experience is required.
  • Experience with ex-US regulatory authorities, including meetings, submissions, and strategy, is desired.
  • Strong regulatory intuition and project management acumen with in-depth CMC regulatory and product development experience.
  • Solid understanding of dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory functions across all phases from pre-phase 1 to marketing application.
  • Excellent written, verbal, interpersonal, and presentation communication skills.
  • Ability to interact effectively with all levels inside and outside the company and establish credibility with program team professionals.
  • Proven ability to build effective teams and foster constructive interactions, including conflict resolution with tact and diplomacy.
  • Critical thinking, strong organizational skills, and ability to manage multiple projects and priorities.
  • Proficiency with MS Project, Visio, Excel, PowerPoint, Word, and shared work environments.

Benefits

  • Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life insurance, disability insurance, and 401(k).
  • Paid time off, holidays, parental leave, and bereavement leave.
  • Starting salary range of $190,000 to $210,000 per year.
  • Flexibility that supports work-life balance.

Interested in this position?

Apply directly on the company website

Apply Now

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