Sr. Manager/Associate Director, Regulatory Writer

Jobgether; USA; Remote; USD 140.000 - 170.000; Vollzeit

Benefits dieser Stelle

Remote work within the United States (

Domestic travel up to 20%

Medical, dental, and vision insurance

401(k) retirement plan with company 2%

Company-paid long-term disability

Company-paid life insurance

Employee Assistance Program (EAP)

Paid holidays and paid time off

Home office stipend and equipment

Zusammenfassung

Jobgether is seeking a Sr. Manager/Associate Director, Regulatory Writing in the United States to lead the development of regulatory documents across global programs. This remote role requires coordinating cross-functional teams, mentoring writers, and ensuring submission readiness.

You will serve as lead author for major submissions, manage external vendors, and drive writing standards in alignment with ICH, GCP, FDA, and EMA requirements to advance innovative therapies.

Qualifikationen

• Bachelor's degree in life sciences or related field.
• 10+ years medical or regulatory writing experience in biotech/pharma/CRO.
• Experience leading authoring for major regulatory documents and submissions.
• Strong knowledge of ICH, GCP, FDA/EMA standards.
• Ability to manage multiple complex projects and timelines.
• Experience leading cross-functional teams through planning, development, review and finalization.

Aufgaben

• Lead planning, authoring, coordination, and delivery of regulatory documents for global development programs and health authority interactions.
• Develop strategic document plans aligned with regulatory milestones and submission timelines.
• Lead authoring for protocols, IBs, CSRs, briefing packages, IND/CTA submissions, and health authority responses.
• Coordinate additional deliverables including Orphan Drug Designations, PIPs, PSPs, annual reports, and updates.
• Integrate information across regulatory, clinical, nonclinical, safety, and CMC functions for consistency and accuracy.
• Lead cross-functional document planning, reviews, and content discussions with SMEs.
• Collaborate with Regulatory Affairs leadership on global strategy and submissions planning.
• Represent Regulatory Writing in project teams and governance meetings; communicate status and risks.
• Establish writing standards, templates, style guides, and development procedures.
• Identify opportunities to improve workflows, review cycles, and submission readiness.
• Manage external vendors and contract writers to ensure quality and timelines.
• Mentor junior writers and contribute to capability development.
• Coordinate finalization and publishing activities for major submissions.
• Ensure alignment with ICH, GCP, FDA, EMA and other international requirements.

Kenntnisse

Regulatory writing leadership

Clinical development knowledge

Cross-functional collaboration

Mentoring/writing leadership

Vendor management

Ausbildung

Bachelor's degree in life sciences

Advanced degree preferred

AMWA certification preferred

Tools

External medical writing vendors

Jobbeschreibung

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Sr. Manager/Associate Director, Regulatory Writer based in the United States.

We are seeking an experienced regulatory writing professional to lead the development and delivery of high-quality scientific and regulatory documentation across global clinical development programs. In this remote role, you will oversee document strategy, author complex regulatory submissions, and coordinate cross-functional contributors to support programs from initial clinical development through marketing applications and lifecycle management. You will partner with experts across Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, and Chemistry, Manufacturing, and Controls (CMC) to ensure scientific accuracy and regulatory compliance. As the primary writing lead for major submissions and health authority interactions, you will establish best practices, strengthen document quality, and maintain submission readiness. You will also mentor writers, manage external vendors, and improve processes that support efficient, consistent document delivery. This is an opportunity to influence global development strategies and contribute to advancing innovative therapies for patients with significant unmet medical needs.

Accountabilities

• Lead the planning, authoring, coordination, and delivery of regulatory documents supporting global development programs, health authority interactions, and marketing applications.
• Develop strategic document plans aligned with regulatory milestones, submission timelines, and broader clinical development objectives.
• Serve as the lead author for complex regulatory documents, including clinical protocols and amendments, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and health authority responses.
• Prepare and coordinate additional regulatory deliverables, including Orphan Drug Designation applications, Pediatric Investigation Plans (PIPs), Pediatric Study Plans (PSPs), annual reports, and development updates.
• Integrate scientific and clinical information across regulatory, clinical, nonclinical, safety, and CMC functions to ensure consistency, accuracy, and clarity throughout submission documentation.
• Lead cross-functional document planning, review meetings, and content discussions, aligning subject matter experts and resolving issues that could affect quality or timelines.
• Collaborate closely with Regulatory Affairs leadership to support global regulatory strategies, submission planning, and interactions with health authorities.
• Represent Regulatory Writing in project teams and governance meetings, communicating document status, risks, and recommendations to relevant stakeholders.
• Establish and maintain writing standards, templates, style guides, and document development procedures that promote consistency and inspection readiness.
• Identify opportunities to improve writing workflows, review cycles, submission preparation, and overall operational efficiency.
• Manage external medical writing vendors and contract writers, as needed, ensuring deliverables meet established quality standards and timelines.
• Mentor junior writers and contribute to the development of organizational regulatory writing capabilities.
• Coordinate document finalization and publishing activities for major submissions, ensuring compliance with applicable regulatory expectations.
• Ensure regulatory documents align with relevant ICH guidelines, Good Clinical Practice (GCP), and applicable FDA, EMA, PMDA, and other international requirements.
• Support preparation for regulatory meetings and agency interactions through clear, scientifically rigorous documentation.

Requirements

• Bachelor's degree in life sciences or a related scientific discipline.
• At least 10 years of medical writing or regulatory writing experience within biotechnology, pharmaceutical, or contract research organization (CRO) environments.
• Demonstrated experience serving as lead writer for major regulatory documents and submissions.
• Extensive hands‑on experience authoring and coordinating clinical protocols, Investigator’s Brochures, Clinical Study Reports, regulatory briefing documents, IND and CTA submissions, and responses to health authority questions.
• Strong knowledge of ICH guidelines, Good Clinical Practice, FDA and EMA requirements, and international regulatory standards.
• Proven ability to independently manage multiple complex writing projects simultaneously while maintaining scientific quality, regulatory compliance, and delivery timelines.
• Experience leading cross‑functional teams through document planning, development, review, and finalization.
• Excellent scientific writing, editing, analytical, and organizational skills, with strong attention to detail and consistency.
• Strong communication and stakeholder management skills, including the ability to facilitate technical discussions, resolve content disagreements, and align multidisciplinary teams.
• Ability to establish effective writing processes, manage competing priorities, and exercise sound judgment in a dynamic development environment.

Preferred Qualifications

• Advanced degree in a scientific discipline, such as a PhD, PharmD, MD, or MS.
• Certification from the American Medical Writers Association (AMWA).
• Experience supporting Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), or New Drug Applications (NDAs).
• Experience in rare disease and pediatric drug development programs.
• Experience supporting biologics development.
• Experience managing external medical writing vendors, consultants, and contract writers.
• Bilingual proficiency in English and Chinese.

Benefits

• Annual salary: $140,000–$170,000.
• Remote work: Work remotely within the United States, with a preference for candidates working in the Pacific Standard Time (PST) zone.
• Travel: Occasional domestic travel of up to 20% for team and client meetings.
• Medical coverage: Medical, dental, and vision insurance for employees and eligible dependents.
• Retirement savings: 401(k) retirement plan with company matching.
• Disability protection: Company-paid long-term disability coverage.
• Life insurance: Company-paid life insurance and accidental death and dismemberment (AD&D) coverage, with additional voluntary coverage available.
• Employee assistance: Access to an Employee Assistance Program (EAP).
• Paid holidays: Company-paid holidays.
• Paid time off: Vacation and paid sick leave.
• Remote work support: Monthly telecommunications stipend and reimbursement for work-from-home equipment.
• Professional impact: Opportunity to lead regulatory writing strategy and contribute to global clinical development and regulatory submissions.
• Leadership opportunities: Scope to mentor writers, improve organizational processes, and influence cross-functional development programs.

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.

Data Privacy Notice:

By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

We appreciate your interest and wish you the best!

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.