Director Regulatory Site CMC (Hybrid) – Post-Approval

BioSpace; Boston (MA); Hybrid; USD 174,500 - 274,230; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid volunteer time off

Well-being benefits

Job summary

A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in the biopharmaceutical industry, with a strong background in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between $174,500 and $274,230 alongside comprehensive benefits.

Qualifications

• 10+ years of overall biopharmaceutical/device industry experience.
• 8+ years of direct Regulatory CMC or Regulatory Device experience required.
• Proven ability to understand and communicate regulatory strategy.

Responsibilities

• Lead site-specific post-approval change management activities.
• Drive the adoption of standardized processes and tools.
• Explore and implement automation technologies.
• Ensure site compliance with global regulatory requirements.
• Facilitate alignment with global Regulatory CMC.

Skills

Global HA requirements understanding

Attention to detail

Leadership

Collaboration

Communication skills

Education

BS/BA Degree in a Scientific Discipline

Advanced Degree (M.S., Ph.D.)

Job description

A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in the biopharmaceutical industry, with a strong background in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between $174,500 and $274,230 alongside comprehensive benefits.