Director, CMC Regulatory Affairs

Larimar Therapeutics • Bala-Cynwyd, PA

85d

About The Position

Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director.

Requirements

• Minimum of 4-year undergraduate degree.
• 10+ years’ experience in a Regulatory Affairs role in the pharmaceutical industry.
• Experience with Health Canada, EMA, MHRA and other local European agencies preferred.
• Understanding of GxP systems and Quality principles.
• Ability to research global regulatory guidance and precedence.
• Knowledge of eCTD structure, components and basic regulatory operations.
• Experience with preparation of high-quality regulatory documents for global Health Authority submissions.
• Excellent communication, time management and project management skills.
• Continuous quality improvement mindset and attention to details.
• Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model.

Nice To Haves

• Can do attitude, flexibility, and mental agility.

Responsibilities

• Manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals.
• Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments and discuss suitable CMC strategies.
• Work closely with RA Sr. Director and serve as backup to other global regulatory activities.
• Define, develop and execute global CMC regulatory strategies based on knowledge of guidelines with practical experience.
• Provide detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval.
• Evaluate proposed manufacturing and quality changes for impact to current Health Authority Applications and provide strategic regulatory guidance.
• Develop and manage the content plans for global M3 CMC submissions or responses.
• Coordinate document authoring, review, and finalization of high-quality CMC documents.
• Manage the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities.

Benefits

• Competitive salary with frequent market benchmarking.
• Incentive stock options.
• Comprehensive benefits plan including 401K.
• Flexible PTO policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees