Associate, Regulatory Publishing in Basking Ridge, New Jersey at DSI

Date Posted: 2/10/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

To perform and oversee the preparation of regulatory submissions in both paper and electronic formats. To provide assistance with preparation, format, update, and proofreading of various clinical and regulatory documents for quality (e.g., INDs’, NDAs’ protocols, clinical trial reports, Investigator’s Brochures, non-clinical reports, etc.) for FDA submission as well as in-house and affiliate/partner distribution. Review and provide feedback on investigational site start up packages to allow the shipment of investigation drug to sites. Updating department’s lists and data bases including ClinicalTrials.gov. Transfer documents into or download documents from Documentum® File System, and DoHA. Process Safety Letter correspondence and other submissions. Also, assist with training and special projects, within the Regulatory Affairs department (processes, SOPs, and project teams). In addition, help implement new technologies and develop procedures for use within Regulatory Operations. Interact with vendors preparing regulatory submissions for Daiichi Sankyo.

Responsibilities:

Prepare, compile, and maintain Regulatory Affair’s INDs, NDAs, Briefing Books, Annual Reports, Liaison/FDA discussion notes, clinical and pre-clinical reports, etc., i.e. documents for submission to FDA. Documents to be included in an FDA submission are sent from all areas of DSI, e.g., Regulatory Affairs, Labeling Review Committee, Clinical Development and from other DS companies, Daiichi Sankyo Europe GmbH (Germany), Daiichi Sankyo Development, Ltd. (UK) and from Daiichi Sankyo Company Ltd in Japan. This responsibility requires incumbent to identify the appropriate procedures and processes to be followed based on type of regulatory submission, and to often meet very tight deadlines. This includes:

  • Full understanding and quality check of all FDA submission documents for completeness and adherence to Regulatory and Company standards, and complete understanding of the FDA’s extensive Document Management Standards and Guidelines.
  • Use of a wide variety of submission compilation tools and procedures to perform submission activities, including Microsoft Office® applications, extensive use of Adobe Acrobat® application features, ISI Toolbox®, InSight Publisher®, Octagon ViewPoint®, Documentum®, scanning, tracking, document assembly, packaging, mailing, distribution, and archiving paper and electronic submissions according to FDA standards. Typical submission size can range from a 1 page document to 30+ volumes, up to 400 pages per volume.
  • Work with outside vendors to facilitate the preparation of eCTD and SPL submissions for FDA and other regulatory agencies around the world
  • Enter information on ClinicalTrials.gov to reflect new investigators and updated investigator information


Assist Manager / Director with training co-workers and new hires, contractors and temporary employees.

Actively provide input pertaining to our Department’s overall processes and procedures to improve our ability to decrease the time needed to prepare certain types of submissions or to improve our compliance with FDA standards.

Maintain / update database and tracking spreadsheets to ensure the timely and accurate retrieval of information should FDA make an inquiry concerning one of our submissions. Responding to certain FDA inquiries rapidly can be extremely important to the Company both financially and in maintaining our reputation with the Agency.

Interact with Managers and Directors, face-to-face or by electronic means, to correct document deficiencies or to clarify submission requirements regarding the preparation of FDA submissions.

On an ongoing basis actively participate in special projects (e.g., developing processes for electronic submissions, implement use of electronic publishing system for additional types of submissions).

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

High School Diploma or equivalent required; College experience a plus.

3-5 years preparing FDA submissions within a Pharmaceutical environment or demonstrated equivalent abilities and skills.

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.