Job Description

Job Responsibilities :

• Lead the development and execution of global regulatory strategies
• Contribute to company culture, strategy, and operations
• Manage the preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator's Brochures (IBs), DSURs, and NDAs
• Manage electronic submission vendor
• Maintain company records of all submissions and correspondence
• Act as the POC for global regulatory authorities (e.g., FDA, EMA, NMPA, PMDA, etc.)
• Strategize, lead, create, and/or manage the development and submission of documents or plans
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the development process
• Provide expert guidance and support to internal stakeholders on all regulatory matters
• Stay current on relevant regulatory affairs trends & industry updates
• Develop & manage budget
• Maintain active INDs/CTAs
• Manage and partner with consultants & CRO partners for US and EU regulatory submissions

Job Requirements :

• PhD, PharmD, or MD in Life Sciences or similar
• 9+ years of experience in regulatory affairs within biotech, therapeutics, cell therapy
• Strong global regulatory experience – FDA, EMA
• Extensive experience in the preparation and submission of INDs, CTAs, and other regulatory filings
• Excellent written and verbal communication skills
• Strong interpersonal and leadership skills
• Must be comfortable and effective as BOTH an individual contributor and collaborative team player in a fast-paced and dynamic small-biotech environment, and throughout the company’s growth
• Flexible, creative thinker and problem-solver
• Ability to effectively communicate and translate requirements between technical and non-technical stakeholders

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