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The Director of Regulatory Affairs will be accountable for delivery of regulatory affairs for the product portfolio, both strategy and operations. This role will need to provide key input into non-clinical and clinical aspects of regulatory preparation, delivering a regulatory strategy for novel therapeutics in oncology and autoimmune disease areas.
Our client is a well-funded biotech startup company focused on novel cancer and autoimmune disease therapy discovery. They’re entering a fast growth track and expanding their team in Waltham, MA.
- Planning and delivery of a regulatory strategy for lead clinical assets.
- Providing guidance to internal multi-disciplinary teams (Non-Clinical functions, Biostatistics, Medical Affairs, Medical Writing, and Pharmacokinetics) on the regulatory requirements to support clinical development.
- Leading multi-disciplinary teams in the authoring of regulatory communications such as regulatory briefing packages.
- Working directly with the FDA, and other regulatory agencies (directly or through vendors), managing preparation for and attendance at assigned meetings, provision of response etc.
- Accountable for submission of high-quality regulatory packages for CTAs, INDs, with subsequent coordination and provision of responses.
- Development of best practices internally to support regulatory documentation readiness, and development and maintenance of regulatory SOPs.
- Effective management of safety update reports.
- Taking the initiative to monitor, analyze, and disseminate intelligence on regulatory policy guidelines, and make recommendations for impact to projects or organizational practices.
- Bachelor’s or advanced degree in life sciences or a science related field preferred, and/or other appropriate knowledge or experience.
- Ten years in regulatory affairs roles in the biotechnology or pharmaceutical industry.
- Knowledge of GMPs, GLPs, and GCPs.
- Must have previous experience in leading FDA interactions.
- Extensive experience of regulatory drug development including product approval/launch.
- Experience in relevant therapy area (small molecules & biologics) is preferred.
- Competitive base salary and benefit package
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