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Manager, Regulatory Affairs

Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: February 25, 2021

Job Description:

Manager, Regulatory Affairs in Basking Ridge, NJ at DSI Job DescriptionJoin a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

This position is responsible for assisting with the preparation, coordination and monitoring of routine US regulatory submissions (e.g., IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings) and responses to requests. This position may lead the development of less complex documents. This position supports lead product/project strategist(s) in the formulation of regulatory strategy, interactions with Health Authorities (HA), RA team members and cross-functional team members. This position supports routine FDA interactions with supervision. This position possesses a moderate level of regulatory affairs knowledge. This position is learning to work with ambiguity, focuses on tactical decisions and escalates issues upward. This position works with a moderate level of independence and autonomy, has some latitude to manage workload within established limitation and decision-making authority and requires limited coaching and mentoring.

Responsibilities:

Regulatory Knowledge: Develops a high level of regulatory knowledge.

FDA Interactions: Supports lead product/project strategist in FDA interactions with minimal supervision. Liaises with FDA project manager/reviewers to resolve, with supervision, any potential issues. Contributes to the appropriate documentation of interaction, decisions and outcomes with oversight from supervisor.

Dossier Submissions: Assists in the preparation, coordination or monitoring of US regulatory submissions; may lead the development of less complex documents. Interacts with senior Regulatory Affairs and cross-functional personnel to define submission logistics and scheduling.

Registration Strategy: Assists in the formulation of registration strategies for products/projects.

Team Interactions: Provides US RA representation on less complex project teams, partnering with more experienced RA members on more complex project teams.

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


Education/Experience:

Bachelor's Degree preferably in a scientific discipline preferred
Advanced degree preferred


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.
Candidates with Disabilities Who Require Assistance Daiichi Sankyo, Inc. provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you have a disability that inhibits your ability to apply for a position through our online application process or you otherwise need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods described below to contact us about your interest in Daiichi Sankyo, Inc. and/or to request an accommodation. Daiichi Sankyo, Inc.
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal Opportunity Employment 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.

Keywords: Daiichi Sankyo, Newark , Manager, Regulatory Affairs, Executive , Basking Ridge, New Jersey

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