Manager Regulatory CMC Strategy (Remote - Anywhere)

Manager Regulatory CMC Strategy (Remote - Anywhere)

This position is posted by Jobgether on behalf of Accede Solutions Inc. We are currently looking for a Manager Regulatory CMC Strategy in Anywhere.

Join a dynamic and collaborative environment where you will play a key role in shaping global regulatory CMC strategies across the product lifecycle. This position involves preparing high-quality regulatory submissions, collaborating with cross-functional teams, and ensuring regulatory compliance across multiple regions. It is ideal for a scientifically driven professional who thrives in a fast-paced, deadline-oriented setting, with the opportunity to make a measurable impact on global product success.

Accountabilities:

• Develop and execute regulatory CMC strategies aligned with global requirements for submissions, approvals, and lifecycle management
• Lead resolution of complex issues, enabling informed decision-making in partnership with internal and external stakeholders
• Collaborate with R&D, Quality, and Regulatory Affairs teams to align on submission content and timelines
• Author and review regulatory CMC submissions including new registrations, variations, renewals, and responses to agency queries
• Ensure accuracy and regulatory compliance of technical documentation and drive timely fulfillment of CMC-related commitments
• Represent CMC on project teams, oversee project execution, and manage assigned regulatory portfolios with minimal supervision
• Mentor junior team members and contribute to broader regulatory or organizational initiatives as needed
  
  
  

• Bachelor's degree in a scientific discipline (minimum); an advanced degree (MS, PhD, PharmD) is preferred
• At least 6 years of pharmaceutical industry experience, including a minimum of 2 years in CMC regulatory authoring
• Solid understanding of pharmaceutical development, manufacturing processes, and cGMP compliance
• Experience with lifecycle management, global regulatory submissions, and post-approval change management
• Strong verbal and written communication skills; comfortable interacting with diverse technical and regulatory audiences
• Proficiency in Microsoft Office and regulatory documentation systems (e.g., Documentum)
  
  
  

• Competitive salary based on experience and qualifications
• Full remote flexibility, allowing you to work from anywhere
• Comprehensive healthcare coverage including medical, dental, and vision
• Paid time off and holidays
• Opportunities for continued professional development and mentorship
• Collaborative and inclusive work culture
  
  

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  Non-profit Organizations and Primary and Secondary Education

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