Remote Regulatory CMC Lead — Cell & Gene Therapy

Syneos Health, Inc.; Washington (District of Columbia); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions for marketed and development products. You will collaborate with cross-functional teams to ensure global regulatory requirements are met and properly integrated into programs.

The role requires strong knowledge of FDA/EMA/ICH guidelines, experience in CMC submissions, and the ability to guide teams across functions to advance product development and

Qualifications

• Bachelor's degree in a life sciences field.
• Experience preparing regulatory CMC submissions.
• Strong knowledge of FDA, EMA, Health Canada and ICH guidelines.
• Excellent communication and project management skills.
• Ability to work with cross-functional teams globally.

Responsibilities

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Skills

CMC submissions

FDA/EMA/ICH guidelines

Regulatory strategy

Cross-functional collaboration

cGMP knowledge

Education

Bachelor's degree in life sciences

Job description

Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions for marketed and development products. You will collaborate with cross-functional teams to ensure global regulatory requirements are met and properly integrated into programs.

The role requires strong knowledge of FDA/EMA/ICH guidelines, experience in CMC submissions, and the ability to guide teams across functions to advance product development and