What are the responsibilities and job description for the Director of Regulatory Affairs position at Benitec Biopharma Inc. (NASDAQ; BNTC)?
About Us : Benitec Biopharma, Inc. is a pioneering biopharmaceutical company dedicated to developing innovative treatments for rare and life-threatening diseases. Our commitment to patients drives our passion for excellence and innovation in drug development.
Job Summary : As the Director of Regulatory Affairs, you will lead and oversee the regulatory strategy and execution for our portfolio of orphan drugs. You will ensure compliance with global regulatory requirements and play a strategic role in exploring accelerated approval pathways, opportunities for increased engagement with the FDA, and maintaining Orphan Drug Designations and related market exclusivities.
Key Responsibilities :
- Lead the development and implementation of regulatory strategies.
- Oversee the preparation, submission, and maintenance of regulatory filings (e.g., Orphan Annual Reports, Meeting Requests / Briefing Packages, BLAs)
- Act as the primary liaison with regulatory agencies, including the FDA, EMA, and other global health authorities.
- Coordinate and lead meetings with regulatory agencies to ensure alignment on development plans and regulatory requirements.
- Provide regulatory oversight and guidance to cross-functional teams, including clinical, nonclinical, and manufacturing departments.
- Stay abreast of regulatory changes and ensure compliance with updated guidelines.
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