Director of Regulatory Affairs

Director, Regulatory Affairs / Regulatory Services

Location: Remote – Applicants must be based in the Eastern or Central U.S. time zones.

Level: Director preferred; experienced Senior Managers will also be considered

Focus: US Regulatory Affairs / FDA

Reports to: Vice President, Regulatory Services

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About the Role

We are seeking an experienced, hands-on Director of Regulatory Affairs / Regulatory Services to join a growing international organization providing regulatory and clinical development services to pharmaceutical and biotechnology companies.

This is an exciting opportunity for a regulatory professional who enjoys combining strategic leadership with hands-on regulatory execution. The ideal candidate will have extensive experience navigating US FDA regulatory requirements, leading agency interactions, preparing regulatory submissions, and managing products throughout their development and commercial lifecycle.

While the organization supports clients globally, the primary focus of this position will be US Regulatory Affairs . Experience with international regulatory requirements is advantageous but not essential.

We are ideally seeking a Director-level professional; however, experienced Senior Managers who are ready to take the next step in their careers are encouraged to apply. The position offers opportunities for professional growth, increased responsibility, and involvement in complex regulatory projects.

Key Responsibilities

US Regulatory Affairs & FDA Interactions

• Serve as a regulatory lead and subject matter expert for US regulatory activities, providing strategic and operational guidance to pharmaceutical and biotechnology clients.
• Lead and manage FDA interactions, including regulatory meetings, communications, and responses to agency inquiries.
• Prepare and coordinate FDA meeting briefing books/packages, including the development of regulatory strategies, meeting objectives, and supporting documentation.
• Develop and implement US regulatory strategies to support clinical development, product registration, and post-approval activities.
• Provide regulatory guidance on FDA requirements, submission strategies, and evolving regulatory expectations.

Regulatory Submissions & Lifecycle Management

• Lead and actively contribute to the preparation, compilation, and submission of Investigational New Drug (IND) applications.
• Prepare, author, and review regulatory documentation for New Drug Applications (NDAs) and Biologics License Applications (BLAs), with demonstrated hands-on experience writing Module 1
• Manage regulatory submissions throughout the product development lifecycle, ensuring accuracy, compliance, and timely delivery.
• Oversee post-approval lifecycle management of US product licenses, including supplements, amendments, annual reports, and other ongoing regulatory maintenance activities.
• Coordinate responses to FDA requests, deficiency letters, and regulatory questions.
• Conduct critical reviews and quality control of regulatory documentation and submissions.

Project Management & Client Engagement

• Lead multiple regulatory projects, ensuring deliverables are completed on time, within budget, and in accordance with client expectations.
• Serve as a key regulatory contact for clients, providing practical solutions to complex regulatory challenges.
• Coordinate cross-functional teams and external stakeholders to ensure successful project execution.
• Manage project timelines, resources, budgets, and regulatory deliverables.
• Prepare regulatory proposals, project scopes, and budgets in collaboration with senior leadership.
• Identify opportunities to expand client relationships and support business development activities.

Leadership & Team Development

• Provide regulatory leadership and mentorship to junior team members.
• Support the development and implementation of internal regulatory processes, procedures, and best practices.
• Contribute to strategic discussions regarding regulatory services, client needs, and business growth.
• Maintain accountability for the quality and timely delivery of regulatory work.
• Balance strategic oversight with direct, hands-on involvement in regulatory activities.

Required Qualifications & Experience

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related scientific discipline, or equivalent relevant experience.
• Extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Strong US FDA regulatory experience , including direct responsibility for regulatory submissions and agency interactions.
• Demonstrated experience leading FDA meetings and preparing regulatory briefing books/packages.
• Hands-on experience preparing and compiling IND applications.
• Experience authoring regulatory submission documentation for NDAs and/or BLAs, including Module 1
• Experience managing post-approval regulatory activities and lifecycle maintenance of US product licenses.
• Proven ability to manage complex regulatory projects independently while meeting timelines and quality expectations.
• Strong understanding of FDA regulations, regulatory pathways, and pharmaceutical development processes.
• Excellent written and verbal communication skills, with the ability to engage effectively with clients, regulatory authorities, and cross-functional teams.
• Ability and willingness to remain hands-on with regulatory submissions and documentation while providing strategic leadership.
• Must reside in the United States.

Preferred Qualifications

• Previous experience at the Director level or as a Senior Manager with the capability and ambition to progress into a Director position.
• Experience working within a regulatory consultancy, CRO, or pharmaceutical/biotechnology service provider.
• Experience supporting regulatory submissions and strategies outside the United States, including EU, UK, or other international markets.
• Experience mentoring regulatory professionals and contributing to departmental development.
• Experience supporting business development, regulatory proposals, and client relationship management.

• Opportunity to take ownership of complex US regulatory projects and work directly with pharmaceutical and biotechnology clients.
• A combination of strategic responsibility and meaningful hands-on regulatory work.
• Exposure to a variety of products, development programs, and regulatory challenges.
• Opportunity to contribute to the growth and development of an international regulatory services organization. xhyhwjd
• Career development opportunities for experienced Senior Managers seeking to advance into a Director-level position.