Regulatory Affairs Consultant, Biosimilars

Worldwide Salaried Open

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:

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