Head Global Regulatory CMC Strategic Operations and Business Excellence

Full time Full day
Cambridge, MA

Job Description

Who You Are

In this key leadership role, you will build and oversee Global RegCMC strategic framework and will support driving deliverables. In addition you will be accountable for building and expanding Global Regulatory CMC writing group and Global Regulatory CMC Project Management capabilities.

The candidate for this role must have proven internal and external leadership and ability to work cross-functionally and globally, and possess strong communication and interpersonal skills.

What You’ll Do

  • Analyze and measure the effectiveness of existing business processes within Global RegCMC and identify the opportunities to improve business practices and processes to maximize resources and achieve operational excellence across the network
  • Create a change with Global RegCMC internal and external stakeholders (including outsourcing partners) to understand functional interdependencies, assess impact on effective processes, develop mutually agreed optimized processes and drive key cross functional initiatives and business improvements
  • Oversee design and implementation of (internal Global RegCMC and cross-functional) re-engineered business processes to maximize efficiency and compliance
  • Optimize RegCMC systems and tools to accommodate business processes and enable accessibility and easy information sharing
  • Work in close collaboration with Global RegCMC Head and leadership team to ensure operational excellence in
    • Resource planning and prioritization
    • Budget tracking
    • External Regulatory Partnership (outsourcing)
    • QMS and compliance
    • CI initiatives
    • Strategic framework
  • Partners with leadership team on developing communication strategy and preparation of announcements, communications and periodic newsletter, when needed
  • Lead and develop 4-7 direct and indirect reports and support entire Global RegCMC organization with 45+ team members


Required Skills

  • Minimum 12 years of experience, preferred 15+ years pharmaceutical/biotechnology industry experience and 8+ years Global CMC regulatory experience and/or Regulatory Operations, plus Bachelor’s Degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
  • Demonstrate excellent leadership and emotional intelligence, along with verbal and written remote working communication skills.
  • Proven ability to mentor, develop, and retain regulatory CMC professionals, including ability to motivate team to perform at their top level.
  • Enthusiastic orientation to teamwork: works collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to reach satisfactory resolution effectively and expeditiously among all involved parties.
  • Demonstrated ability to execute on a global regulatory strategy and ensure that results are in alignment to the business’ priorities. Demonstrated competency in planning and tracking projects of high complexity and risk with clearly defined critical paths; delivering projects on time and on budget.
  • Proven ability to obtain results in a global, cross-site matrix environment. Ability to manage projects across global locations/time zones. Proven ability to create strong working relationships in a global setting with many different cultures.
  • Demonstrated Project Management skills.


Graduate degree highly preferred

Additional Information

About This Role

This individual will be responsible for developing and executing a focused effort to improve operational effectiveness alongside strategic roadmaps for RegCMC globally. In this role, you will lead an effective team towards delivering upon key strategic operations and business objectives. You will help Global RegCMC leadership and stakeholders drive operational excellence, prepare and facilitate strategic decision making, and enhance systems with an overall goal of increasing efficiency, business priorities and regulatory compliance across all modalities and stages of development.

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