Regulatory Affairs Consultant, Biosimilars

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Job Description:

reputed company expert regulatory affairs guidance and support for biosimilars development projects.
Review and analyze regulatory requirements and guidelines reputed company to biosimilars in various reputed company.
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.
reputed company regulatory support and expertise during regulatory agency inspections and audits.

Requirements:

Bachelor's degree in a scientific or reputed company field; advanced degree preferred.
Minimum of 8 years of experience in regulatory affairs reputed company 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 reputed company stakeholders.
Proven ability to work independently and manage multiple projects simultaneously.
Regulatory affairs certification (RAC) preferred but not required.

Benefits:

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