Senior Manager, Regulatory Affairs

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Regular Full-Time Burlington, MA, US

4 days ago Requisition

Senior Manager, Regulatory Affairs

Reporting to the Director, Regulatory Affairs, the Senior Manager, Regulatory Affairs independently manages, evaluates, and completes complex regulatory projects consistent with company goals. The position is responsible for the timely planning, coordination, and execution of regulatory submissions and for providing clear, practical regulatory strategy and guidance to cross-functional teams.

The Senior Manager must work with a high degree of independence, exercise sound judgment, act quickly when regulatory or business needs arise, and proactively identify and advance activities without waiting for immediate direction. The role supports a varied portfolio of products and must effectively interpret and apply differing regulatory requirements across product types, development stages, and product life cycles.

This position is on-site Monday-Thursday at our Burlington, MA office, with the ability to work remotely on Fridays.

• With minimal supervision, independently plan, prioritize, and manage regulatory activities across assigned development and commercial products. Develop and implement regulatory strategies that support timely approvals, continued compliance, and company objectives.
• Manage the assembly and timely submission of applications (i.e., INDs, BLAs and other dossiers) as required for investigation and registration of biologics.
• Proactively assess priorities, identify regulatory risks and opportunities, make timely recommendations, and escalate significant issues with proposed solutions or mitigation plans.
• Respond rapidly and effectively to changing regulatory requirements, health authority requests, emerging product issues, and shifting business priorities while maintaining the quality and compliance of regulatory deliverables.
• Ensure regulatory submissions are maintained in compliance with regulatory requirements.
• Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
• Serve as the regulatory lead or subject‑matter expert on cross‑functional project teams and provide timely, decisive guidance across a variety of products, regulatory pathways, and applicable requirements, including biologics and combination products, as assigned.
• Develop and maintain current regulatory knowledge and advise management of significant developments.
• Contribute to internal improvements related to best practices and SOPs.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed

• 8+ years of progressive Regulatory Affairs experience in the biotechnology or pharmaceutical industry, including substantial experience supporting biologics.
• Demonstrated experience independently leading complex regulatory projects, developing regulatory strategy, and driving cross‑functional submissions through completion with limited oversight.
• Demonstrated ability to rapidly adapt to changing regulatory and business priorities, act with an appropriate sense of urgency, and make timely decisions while maintaining regulatory compliance and deliverable quality.
• Previous experience with combination products and/or botanicals a plus.
• Experience and knowledge in preparation of BLA submissions and supportive amendments and supplements.
• Experience with prescription drug advertising regulations and promotional review committee.
• Experience with labeling regulations.
• Working knowledge of FDA regulations and…