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.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

#LI-CL1