Manager Regulatory Affairs

Emmes•Rockville, WA

4d•Remote

About The Position

The Manager, Regulatory Affairs is a regulatory strategy leader who advises both internal teams and external clients, bringing deep regulatory expertise to navigate complex development pathways and facilitate productive dialogue with FDA. This role combines strategic advisory skill with people leadership, managing and developing a small team of Regulatory Affairs professionals while remaining hands-on with the technical and operational work that underpins sound regulatory strategy. The Manager acts as a trusted partner in client-facing conversations, bringing the regulatory depth and confidence needed to speak knowledgeably on US regulatory strategy — including IND development, FDA meeting strategy, and approval pathways — and to represent the organization credibly in discussions with potential and existing clients. Internally, the Manager guides teams through regulatory decision-making, anticipates FDA engagement needs, and ensures regulatory deliverables meet the highest standards of quality and compliance. Beyond strategic advising, the Manager oversees regulatory operations to ensure submissions are well-organized, on schedule, and audit-ready, and supports the growth and performance of assigned employees.

Requirements

Bachelor's degree in life sciences, pharmacy, healthcare, or a related field; advanced degree preferred.
Typically, 6–8+ years of relevant Regulatory Affairs experience within a CRO, pharmaceutical, biotechnology, or clinical research environment.
1-3 years management experience.
Demonstrated experience independently managing complex regulatory activities and submissions.
Experience in U.S. government-funded research networks is a plus.
Prior experience leading, mentoring, or supervising regulatory professionals; formal people-management experience preferred.
Strong knowledge of applicable global clinical research and regulatory requirements.
Demonstrated ability to balance technical regulatory responsibilities with employee leadership and resource management.
Strong leadership, project management, analytical, problem-solving, and organizational skills.
Excellent written and verbal communication skills.
Ability to effectively manage competing priorities within a fast-paced, global environment.

Responsibilities

Lead regulatory activities for assigned clinical development programs, studies, or client projects.
Develop, implement, and oversee regulatory strategies aligned with study objectives, development plans, and applicable regulatory requirements.
Provide expert regulatory guidance regarding clinical trial applications, submissions, amendments, notifications, and other regulatory documentation.
Oversee the preparation, review, coordination, and submission of regulatory packages to regulatory authorities and ethics committees/IRBs, as applicable.
Interpret and apply relevant global and regional regulatory requirements, including FDA, EMA, MHRA, ICH, EU CTR, and applicable country-specific regulations.
Serve as a regulatory subject matter expert for assigned programs and provide guidance to cross-functional project teams.
Identify regulatory risks and issues and develop appropriate mitigation strategies.
Ensure regulatory activities and deliverables are completed accurately, compliantly, and within established timelines.
Support regulatory authority interactions and responses to regulatory questions and requests for information.
Partner with Clinical Operations, Study Start-Up, Quality, Safety/Pharmacovigilance, Medical, and other functions to ensure regulatory alignment.
Support client meetings, proposal development, bid defenses, audits, and regulatory inspections, as required.
Critically review and provide input on protocols, ICFs, initial IND/pIND/IDE applications, CSRs, PK reports, annual IND reports, 510(K), and responses to information requests from regulatory agencies.
Participate in regular meetings with the collaborators, sponsors, and FDA.
Participate in protocol team calls, as necessary.
Develops TOROs and related agreements.
Make submissions to Canadian health authorities.
Provide direct supervision and leadership to of up to 10 Regulatory Affairs employees.
Establish goals and expectations and provide ongoing coaching, feedback, and development support.
Conduct performance discussions and contribute to performance evaluations, compensation recommendations, and talent-development decisions.
Support employee onboarding, training, career development, and succession planning.
Allocate work and monitor employee workloads, priorities, quality, and delivery.
Provide technical and professional guidance to team members and support resolution of complex regulatory issues.
Foster collaboration, accountability, continuous learning, and consistent regulatory practices across the team.
Participate in recruitment, interviewing, and selection activities as needed.
Support the development and continuous improvement of regulatory department processes, procedures, templates, systems, and best practices.
Monitor team capacity and resource requirements and escalate potential staffing or delivery risks.
Support consistent application of regulatory standards and quality expectations across projects.
Monitor regulatory trends and changes and communicate relevant implications to employees, project teams, and leadership.
Contribute to departmental objectives and initiatives in partnership with senior Regulatory Affairs leadership.
Performs other duties as assigned.
Complies with all policies and standards.