Associate Director, Regulatory Writing

Daiichi Sankyo Co.; Basking Ridge (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Writing to lead the creation of high-quality regulatory documents (CSRs, NDA/MAA submissions, briefing books) and support strategic input for filings.

The role demands strong medical writing expertise, knowledge of regulatory requirements and ICH guidelines, with 4+ years (graduate degree) or 7+ years (Bachelor’s) in the field; travel up to 5%. Collaborating across clinical, regulatory, and submissions teams, you will drive timelines,

Qualifications

• Bachelor's degree in a relevant science field required.
• Master's degree or PhD preferred.
• 4+ years of medical writing with graduate degree or 7+ years with Bachelor's required.
• Experience writing submission documents (NDA/MAA/BLAs) required.

Responsibilities

• Write critical, complex clinical and clinical pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) with minimal input from functional area experts.
• Ensure key messages are clear and consistent within and across documents
• Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
• Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests
• Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
• Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations and drive changes as needed.
• Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes

Skills

Regulatory writing

Medical writing

ICH guidance

Education

Bachelor's Degree

Master's Degree or PhD in relevant science field

Job description

Job Title: Associate Director, Regulatory Writing

Job Requisition ID: 2340

Posting Start Date: 10/14/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

The Associate Director, Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs.. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director, Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).

Job Description

Responsibilities

• Write critical, complex clinical and clinical pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) with minimal input from functional area experts;
• Ensure key messages are clear and consistent within and across documents
• Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
• Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests;
• Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
• Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations and drive changes as needed.
• Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes

Qualifications

Education Qualifications

• Bachelor's Degree required
• Master's Degree or PhD in relevant science field preferred

Experience Qualifications

• 4+ years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field or 7+ years of experience as a medical writer with a Bachelor's degree in a relevant science field required
• Submission document writing experience required

Travel Requirements
Ability to travel up to 5% of the time. In-house/remote office position that may require domestic/global travel.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.