Associate Director, Regulatory Strategy

Company Summary:

Inozyme Pharma is a biotechnology company committed to developing novel medicines for the treatment of rare metabolic diseases characterized by mineral imbalances. We are singularly focused on developing new therapies for patients with devastating rare diseases.  The company was founded in 2016 with technology licensed from Yale University and is well financed by a premier syndicate of venture investors.  Inozyme Pharma is led by an experienced management team with a proven track record in rare disease drug development, regulatory approvals, manufacturing and operations.

Our employees are central to our ability to achieve our goals of helping patients. We’re looking for people to join our team who are collaborative, compassionate, resilient, and passionate about what we do.

Description:

Associate Director, Regulatory Strategy

Inozyme Pharma is searching for an Associate Director, Regulatory Strategy to join their growing Regulatory Affairs team.  As a Associate Director, Regulatory Strategy, this individual will be responsible for guiding regulatory strategy and leading global health authority interactions to support global development from early development through registration and life cycle management.

Responsibilities:

• Develop and execute regulatory strategy for long-term development planning including the potential to accommodate expedited development needs
• Guides and executes regulatory strategy in support of development
• Plans, prepares, coordinates, and writes (when applicable) compliant and high-quality regulatory submissions (i.e. clinical trial applications, formal meeting documentation, life-cycle management submissions);
• Leads preparation and submission of marketing applications, as applicable
• Drives and organizes preparation for global HA meetings, teleconferences, and written interactions
• Collaborates effectively with cross-functional teams and defines regulatory expectations, while also providing regulatory guidance
• Engage with Regulatory Authorities on project related matters
• Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
• Acts as regulatory representative on early and late phase clinical studies, ensuring successful and compliant execution of trials
• Ensure frequent updates and alignment with manager regarding regulatory strategy/plans for drug program

Education/Qualifications:

Requirements:

• Bachelor’s degree in a scientific discipline required; advanced degree a plus
• Must have a minimum of 7+ years pharmaceutical industry experience in global regulatory affairs; preferably with experience in rare or ultra rare diseases
• Must have Regulatory Strategy experience with a focus on Biologics
• Experience leading IND and CTA filings and led Agency meetings.
• Gene Therapy experience preferred
• Experience with early phase – post market
• Preference would be US/EU, but ROW is a bonus.
• Solid knowledge of drug development; FDA, EMA and ICH guidelines and regulations
• Excellent project management, organizational, and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment; Strong interpersonal skills and the ability to effectively work and collaborate with others
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Driven individual, who executes and operates to a high standard

Full-Time - Boston

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EEOC Statement:
‍To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job’s alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.