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