Global Regulatory Affairs Lead, CMC Strategy

BioSpace; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus programs

Stock incentives

Flexible work arrangements

Job summary

A leading biotechnology company is seeking a Regulatory Affairs Senior Manager to contribute to product teams and provide strategic regulatory input. This leadership role involves executing regulatory strategies, engaging with regulatory agencies, and guiding teams in compliance with CMC requirements. The ideal candidate will have a robust educational background and experience in more than one aspect of regulatory affairs.

Qualifications

• Doctorate OR Masters + 3 years experience OR Bachelors + 5 years OR Associates + 10 years OR High school diploma/GED + 12 years experience.
• Experience in manufacture, testing, or distribution; Regulatory CMC experience preferred.

Responsibilities

• Generate and execute global and country-specific regulatory strategies.
• Provide CMC regulatory strategy for projects.
• Liaise with development, operations, and commercial teams.

Skills

Regulatory strategy

Risk assessment

Change management

Education

Doctorate

Masters

Bachelors

Associates

High school diploma/GED

Job description

A leading biotechnology company is seeking a Regulatory Affairs Senior Manager to contribute to product teams and provide strategic regulatory input. This leadership role involves executing regulatory strategies, engaging with regulatory agencies, and guiding teams in compliance with CMC requirements. The ideal candidate will have a robust educational background and experience in more than one aspect of regulatory affairs.