Regulatory Affairs Consultant, Biosimilars

Job Description:

• Provide expert regulatory affairs guidance and support for biosimilars development projects.
• Review and analyze regulatory requirements and guidelines related to biosimilars in various regions.
• Assist in the preparation, submission, and maintenance of regulatory submissions for biosimilars, including INDs, BLAs, and variations.
• Collaborate with cross-functional teams to ensure alignment on regulatory strategy and objectives.
• Stay updated on regulatory developments and trends impacting biosimilars globally.
• Participate in meetings with regulatory authorities as needed.
• Provide regulatory support and expertise during regulatory agency inspections and audits.

Requirements:

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with specific expertise in biosimilars preferred.
• 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.
• Regulatory affairs certification (RAC) preferred but not required.

Benefits:

• Competitive compensation packages are available

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