Manager Regulatory Affairs

Location
Basking Ridge, New Jersey, United States
Posted
Sep 13, 2019
Ref
9945BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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:

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:
  • Qualified candidates must have a Bachelor's degree from an accredited college or university; preferably in a scientific discipline
  • Prefer an advanced degree (e.g., Masters, Pharm.D., Ph.D.)
  • Experience in the pharmaceutical industry required with 2+ years direct regulatory
In-house office position that may require 5% occasional travel (global).

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.
Job Title
Manager Regulatory Affairs

City
Basking Ridge

Functional Area
Regulatory Affairs Oncology

State
New Jersey