CMC Regulatory Affairs Lead for Global Submissions

Cytokinetics, Inc.; Radnor (Delaware County); Hybrid; USD 177,000 - 207,000; Full time

Benefits offered by this job

Health, Dental, Vision, Life Insurance

Disability insurance

401(k) with employer match

Stock options / RSUs

Learning & wellness stipends

Paid time off

Job summary

Cytokinetics, Inc. is seeking a Senior Manager, Regulatory Affairs – CMC to drive CMC regulatory filings and strategy in a hybrid role based in Radnor, PA.

You will coordinate cross-functional teams across Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain to ensure timely, accurate submissions for US and EU markets. Ideal candidates have 5+ years in pharma/biotech regulatory affairs with CMC focus, strong knowledge of GDP/GMP, and experience with VEEVA RIM/EDMS

Qualifications

• 5+ years as Regulatory professional in pharma/biotech (CMC focus)
• 2–3 years in Regulatory Affairs-CMC
• Bachelor’s degree; science/pharmacist preferred; advanced degree preferred
• Familiarity with global regulatory guidelines for CMC development and commercialization
• Understanding of US/EU regulatory expectations, GDP/GMP
• Experience generating technical registration dossiers for US/EU
• Knowledge of submission processes and systems (Module 2.3/3, VEEVA)
• Strong written and verbal communication; ability to influence and resolve conflicts

Responsibilities

• Lead/co-ordinate execution of CMC regulatory filing strategy
• Manage regulatory processes to achieve timely submission
• Prepare high-quality CMC regulatory documents per company standards
• Collaborate with RA, QA, and Technical Operations across the value chain
• Monitor regulatory changes to inform strategy and stage-specific requirements
• Support or lead regulatory-related QA processes and system changes

Skills

Regulatory strategy

Cross-functional collaboration

Documentation & dossiers

Regulatory interpretation

GDP/GMP knowledge

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

VEEVA – RIM/EDMS

eCTD submissions

Job description

Cytokinetics, Inc. is seeking a Senior Manager, Regulatory Affairs – CMC to drive CMC regulatory filings and strategy in a hybrid role based in Radnor, PA.

You will coordinate cross-functional teams across Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain to ensure timely, accurate submissions for US and EU markets. Ideal candidates have 5+ years in pharma/biotech regulatory affairs with CMC focus, strong knowledge of GDP/GMP, and experience with VEEVA RIM/EDMS