layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Manager, Regulatory Operations at Prime Medicine

Submission Planning & Execution: Lead end-to-end planning and execution of regulatory submissions, including INDs/CTAs, BLAs/MAAs, amendments, annual reports, and briefing packages.
Timeline & Risk Management: Develop and maintain integrated regulatory timelines, track milestones and dependencies, identify critical-path risks, and drive mitigation plans.
Cross-Functional Coordination: Partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners to compile, quality-check, and finalize submission content.
Health Authority Interactions: Support preparation for health authority meetings, including briefing books, logistics, meeting minutes, and action item tracking.
Information Requests: Track incoming health authority information requests (IRs) and coordinate timely, well-organized responses across functional teams.
Document & Systems Management: Manage regulatory publishing and document management systems, ensuring submissions meet eCTD and other applicable technical standards.
Process & Compliance: Maintain regulatory operations SOPs and tracking systems; identify and implement process improvements to increase efficiency and quality.
Vendor & Budget Oversight: Support management of regulatory operations vendors and budget, including publishing and translation vendors.
Required Qualifications
Bachelor's degree in life sciences, regulatory affairs, or a related field.
7+ years of experience in regulatory affairs or regulatory operations within the pharmaceutical or biotechnology industry.
Demonstrated experience managing IND/CTA and BLA/MAA submissions from planning through filing.
Strong working knowledge of eCTD structure, regulatory publishing tools, and document management systems (e.g., Veeva Vault RIM or similar).
Proven project management skills, with the ability to manage multiple concurrent programs and competing priorities.
Excellent written and verbal communication skills, with strong cross-functional collaboration and stakeholder management abilities.
High attention to detail and a strong quality mindset.

Senior Manager, Regulatory Operations

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Equal opportunity and accommodations

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