The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regulatory Affairs based in United States.
This is a strategic regulatory leadership role supporting innovative biologic development programs in oncology. You will lead regulatory strategy across U.S. and international markets, helping shape development pathways and submission plans. The role offers broad exposure to clinical development, global health authorities, and novel cell and gene therapy programs. You will work closely with cross-functional leaders to align regulatory strategy, manage risks, and advance programs efficiently. You will also lead preparation for health authority interactions and contribute to high-quality clinical and regulatory submissions. Success in this role requires strong scientific judgment, clear communication, attention to detail, and the ability to influence complex decisions. This fully remote opportunity offers a base salary of $185,000–$210,000 and the opportunity to contribute to innovative oncology therapies.
Accountabilities:
- Develop and execute U.S. and global regulatory strategies for assigned development programs.
- Collaborate with functional leaders to establish optimal clinical and regulatory development pathways.
- Help negotiate development strategies within cross-functional teams and with health authorities.
- Execute clinical-regulatory development plans on schedule while identifying and managing program risks.
- Plan, manage, and prepare Clinical Trial Applications, Marketing Applications, and regulatory amendments.
- Ensure submission documents and regulatory correspondence meet high standards for content, organization, clarity, and accuracy.
- Lead cross-functional teams in developing strategic briefing packages.
- Coordinate preparation for health authority meetings, discussions, and other regulatory interactions.
- Support regulatory interactions with agencies including Health Canada, MHRA, EMA, Swissmedic, and TGA.
- Monitor evolving global regulations, guidelines, and health authority expectations relevant to biologics and advanced therapies.
- Incorporate changing regulatory requirements into program strategy and decision-making.
- Collaborate with internal teams to identify and implement regulatory process improvements.
- Contribute to the development of high-quality clinical-regulatory documents and supporting materials.
- Manage multiple projects and submissions simultaneously, adapting priorities as new data, program changes, or external developments arise.
- Perform additional regulatory and cross-functional responsibilities as needed.
- Bachelor’s degree in life sciences required.
- Minimum of 5 years of regulatory affairs experience with a doctorate such as MD, PhD, PharmD, or equivalent.
- Alternatively, 8 years of regulatory affairs experience with a master’s degree or 10 years with a bachelor’s degree.
- Demonstrated experience supporting late-stage oncology drug development programs.
- Experience developing and negotiating clinical-regulatory strategies with health authorities, including ex-U.S. agencies.
- Experience with the creation, submission, and negotiation of regulatory applications is preferred.
- Ability to develop, write, edit, and/or collaborate on high-quality clinical-regulatory documents.
- Experience with materials such as briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.
- Strong ability to communicate clearly and concisely within established timelines.
- Ability to manage multiple regulatory projects and submissions simultaneously.
- Flexibility to adjust priorities in response to new clinical data, program changes, and external regulatory developments.
- Exceptional attention to detail and commitment to accuracy.
- Strong organizational, planning, and project management skills.
- Ability to influence and negotiate professionally with cross-functional teams and external partners.
- Excellent interpersonal, verbal, and written communication skills.
- Strong judgment, analytical thinking, troubleshooting, and problem-solving abilities.
- Advanced degree such as MS, MPH, PharmD, or PhD preferred.
- Experience with biologics, cell and gene therapies, or advanced therapy medicinal products is preferred.
- Ability to work effectively in a remote professional environment.
- Salary: $185,000–$210,000 USD annual base salary.
- Work Model: Fully remote position.
- Career Scope: Leadership responsibility across U.S. and global regulatory strategies and submissions.
- Global Exposure: Opportunities to engage with regulatory authorities across North America, Europe, Australia, and other international markets.
- Scientific Environment: Work involving innovative biologic development and novel cell and gene therapy approaches in oncology.
- Cross-Functional Collaboration: Partner with clinical development and other functional leaders on complex development programs.
- Professional Growth: Exposure to regulatory strategy, health authority interactions, clinical development, and global submissions.
- Work Environment: Professional remote-office setting with standard office equipment and computer-based work.
- Accessibility: Reasonable accommodations are available to support qualified individuals in performing the essential functions of the role.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
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