Regulatory Affairs – Biosimilars Consultant

Job Description: • This is a remote position. • 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: Apply tot his job Apply tot his job

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