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Associate Director/Director, Regulatory Affairs - CMC in Bernards, NJ at DSI

Date Posted: 4/13/2019

Job Snapshot

Job Description

oin 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 serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team, and serves as Integrated Project Team (IPT) ad hoc member for late stage projects. This position manages multiple biological developmental and post marketing projects with supervision, including 3rd party developments. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents. These include clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison with the Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections). Additionally, this position has direct interaction with research laboratory members, the Contract Sales Organization (CSO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation.
Responsibilities
Planning for Development and Post Marketing Projects: Manages multiple CMC development and post marketing projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.
Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.
Health Authority Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager.
Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company initiatives.

Qualifications:

Education and Experience
  • M.S./PhD. in a scientific discipline
  • 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or PhD. in a scientific discipline with 6-8 years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experience
Director:
  • M.S. in a scientific discipline, Ph.D. in a scientific discipline preferred
  • 10-12 years in pharmaceutical industry experience with 5+ years direct CMC regulatory experience
  • Recent experience in the support of successful submissions and approval of submissions through the Centralized, Mutual Recognition, and National procedures and in post-license variations.
Compensation and seniority level/title will be commensurate with experience and qualifications. Duties and responsibilities may vary based on the position level/title.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.