Job Description

Associate Director, Regulatory Affairs – Biosimilar/BLA

Description:

Regulatory expert in the area of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of Biologics. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives.

Essential Functions:

• Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks.
• Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (e.g., BLA, MAA). Identify required documentation and ensure timely, high-quality submissions meeting global requirements.
• Health Authority Interactions and Negotiations: Initiate and lead Health Authority interactions, including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory issues.
• Provide Regulatory Guidance and Compliance Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents.
• Support Development, Submission, and Post-Approval Activities: Collaborate on development, submission, and post-approval activities from a regulatory perspective. Maintain partnerships with internal and external stakeholders to ensure smooth regulatory processes.

Additional Responsibilities:

• Maintain awareness of all regulatory activities regarding new and approved drug products. Stay current with state-of-the-art standards on the regulatory process.

Qualifications for Internal Candidates

Education:

• Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required

Experience:

• 11 years or more in Regulatory Affairs in Biosimilar/ BLA regulatory submissions

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