Regulatory Affairs Operations Manager

Merida Biosciences•Cambridge, MA

3d•$130,000 - $160,000

About The Position

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. The Manager, Regulatory Operations will play a key role in supporting global regulatory activities across Merida Biosciences’ development programs. This role will focus on regulatory submission planning, execution, and lifecycle management, working closely with Regulatory Affairs leadership and cross-functional teams to ensure high-quality, timely regulatory submissions. This is a hands-on role requiring strong organizational skills, attention to detail, and the ability to manage complex regulatory deliverables in a fast-paced biotech environment. The Manager will help drive operational excellence across regulatory processes, systems, and submission planning while supporting global regulatory strategies for company programs.

Requirements

Bachelors Degree in Life Sciences or related discipline. Advanced degree (MS, MBA) or PMP certification preferred.
5+ years of relevant experience within Regulatory Affairs/Regulatory Operations in the pharmaceutical or biotechnology industry.
Working knowledge of the drug development process and global regulatory frameworks.
Experience working with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools. Experience with Veeva Vault Regulatory preferred.
Experience coordinating with or overseeing external publishing service providers for regulatory submissions is desirable.
Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as MS Teams
Experience with project planning and tracking tools (e.g., Smartsheet, Microsoft Project or similar) to support regulatory timelines and deliverables.
Knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats.
Excellent organizational, communication, and project management skills with the ability to manage multiple priorities simultaneously.
Ability to work effectively in a collaborative, fast-paced small company environment.

Responsibilities

Support the planning, coordination, and execution of global regulatory submissions, including INDs, CTAs, BLAs, NDAs, MAAs, and amendments, ensuring compliance with global regulatory requirements and timelines.
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions.
Coordinate regulatory submission activities including document readiness, publishing, quality control, and electronic submission (eCTD) processes.
Partner with Regulatory Affairs leadership and functional teams to facilitate submission planning and maintain integrated regulatory submission plans across programs.
Support preparation and operational coordination of regulatory agency interactions, including briefing document planning and submission logistics.
Monitor and track submission deliverables and milestones, identifying risks and proactively working with stakeholders to mitigate potential delays.
Maintain regulatory documentation, submission records, and regulatory information within regulatory systems and document management platforms.
Ensure compliance with global regulatory submission standards, including eCTD structure, formatting, and publishing requirements.
Contribute to the development and implementation of regulatory operations processes, tools, and best practices to improve efficiency and consistency across programs.
Support lifecycle management activities, including post-approval submissions, amendments, annual reports, and regulatory correspondence.