Remote Biosimilars Regulatory Affairs Consultant

Pharmavise Corporation; United States; Remote; USD 120,000 - 180,000; Part time

Benefits offered by this job

Competitive compensation

SME network access

Job summary

PharmaviseConsulting Corp. seeks a Regulatory Affairs Biosimilars Per Diem Consultant to guide regulatory programs from development through approval. You will review requirements, prepare submissions, and coordinate with cross-functional teams to align regulatory strategy.

The role demands a strong biosimilars background, experience with INDs/BLAs, and international guidelines, with 8+ years in regulatory affairs; RAC preferred. Remote contract position with competitive compensation.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs within the pharmaceutical/biotech industry, biosimilars preferred.
• RAC certification preferred but not required.
• Experience with regulatory submissions for biosimilars (INDs, BLAs, variations).

Responsibilities

• Provide expert regulatory affairs guidance for biosimilars development projects.
• Review and analyze regulatory requirements and guidelines for biosimilars globally.
• Assist in preparation, submission, and maintenance of regulatory submissions (INDs, BLAs, variations).
• Collaborate with cross-functional teams to align regulatory strategy and objectives.
• Stay updated on regulatory developments impacting biosimilars worldwide.
• Participate in meetings with regulatory authorities as needed.
• Provide regulatory support during inspections and audits.

Skills

Regulatory affairs

Biosimilars expertise

Regulatory submissions

Project management

Education

Bachelor's degree in science

Job description

PharmaviseConsulting Corp. seeks a Regulatory Affairs Biosimilars Per Diem Consultant to guide regulatory programs from development through approval. You will review requirements, prepare submissions, and coordinate with cross-functional teams to align regulatory strategy.

The role demands a strong biosimilars background, experience with INDs/BLAs, and international guidelines, with 8+ years in regulatory affairs; RAC preferred. Remote contract position with competitive compensation.