Regulatory Affairs Biosimilars Per Diem Consultant
RemoteUnited States
Job Summary
Provide expert regulatory affairs guidance and support for biosimilars development projects, reviewing requirements and analyzing guidelines across various regions. Assist in the preparation, submission, and maintenance of regulatory submissions including INDs, BLAs, and variations while collaborating with cross-functional teams to ensure alignment on regulatory strategy. Stay updated on global regulatory developments and participate in meetings with regulatory authorities as needed. Offer regulatory support and expertise during agency inspections and audits. This role requires a minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with specific expertise in biosimilars preferred. Competitive compensation is available for this remote per diem position.
Required Qualifications
- Bachelor's degree in a scientific or related field
- Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Strong understanding of regulatory requirements and guidelines governing biosimilars development and approval processes
- Experience with regulatory submissions for biosimilars, including INDs, BLAs, and variations
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders
- Proven ability to work independently and manage multiple projects simultaneously
Desired Qualifications
- advanced degree
- specific expertise in biosimilars
- Regulatory affairs certification (RAC)
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