Manager/Senior Manager, Regulatory Affairs

Inozyme is seeking a Manager/Senior Manager to join our growing Regulatory Affairs team.  This individual will work closely with the Associate Director of Regulatory Affairs to define, develop, and implement regulatory strategies towards achievement of program objectives and to provide strategic and tactical guidance to cross-functional teams to achieve timely and efficient development of programs, while ensuring compliance with applicable regulatory requirements.

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Essential Duties and Responsibilities:

• Working with the Associate Director of Regulatory Affairs, develop and implement global regulatory strategies consistent with company goals and strategy
• Prepare and coordinate regulatory correspondence and submissions 
• Identify and assess opportunities for innovative regulatory approaches to support product development
• Serve as regulatory lead on project teams
• Provide guidance to cross-functional teams on regulatory strategy and activities
• Perform regulatory research and intelligence
• Support regulatory agency inspection readiness activities
• Participate in process improvement activities

Desired Skills & Experience:

• B.S (or equivalent) in a scientific discipline. Advanced degree (MS, PharmD) a plus
• At least 5 years of biotech/pharma industry experience, with a minimum of 3 years of experience in Regulatory Affairs
• Experience in developing and finalizing successful regulatory submissions to FDA; experience with other regulatory authorities is a plus
• Working knowledge of FDA regulations, eCTD, and ICH guidelines
• Understands and interprets scientific issues as it relates to regulatory requirements and strategy
• Ability to work independently with minimal direction and in a team environment
• Excellent oral and written communication skills
• Detail-oriented and with strong operational skills, including planning, organizing, and the ability to motivate others
• Excellent interpersonal skills with a collaborative, team-oriented mindset

Position

Full Time - Boston

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