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

Date Posted: 11/13/2018

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:

This position serves as the EU Regulatory Affairs (RA) CMC member for all assigned developmental projects and for life-cycle management of approved product in the European Union. This position executes the EU regulatory strategy and provides regulatory support and guidance to the RA CMC members supporting development projects and life cycle management based upon EU regulatory experience and knowledge of EMA and national guidances. This position will effectively liaise, negotiate and partner with EU health authorities with support from higher level management and represent RA CMC as the EU representative to the CMC sub team, the RA team and the Integrated Project Team (IPT) as an ad hoc member for late stage projects. This position provides the EU guidance on critical issues, amends the global dossier core documents so that they are fit for purpose for submission in the EU (e.g., IMPD, CTA, MAA, Amendments, and Variations). The position leads RA CMC with support from higher level management in EU CMC Health Authority Meetings (e.g., Scientific Advice Meetings, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. Additionally, this position has strategic interaction with labeling, clinical, non-clinical (Translational Medicine and Clinical Pharmacology—TMCP) and toxicology.

This position works with normal problems requiring solutions for which there is regulatory precedent and acts as a decision-maker with consultation.

Responsibilities

Manages multiple CMC development and post marketing projects for EU submission. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on EU RA CMC project issues.

Develops EU RA CMC strategy with supervision for the EU RA CMC expert. Amends global dossier for EU submissions with the technical team in preparation of EU submission documents. Authors EU regulatory documents where necessary under the guidance of the EU RA CMC expert. Assures EU regulatory submissions are made in the timely and accurate manner to obtain and maintain approvals of applications for Clinical Trials (CTAs/IMPDs) and Market Authorization Applications (MAAs).

Leads EMA and National Health Authority interactions with support from higher-level manager.

Has direct EU regulatory experience dealing with the EMA and National Health Authorities on the submission of IMPD/CTAs and MAAs and their variations for post-license life-cycle management. Has experience in submissions through the Centralized Procedure, Mutual Recognition, and National procedures. Has and demonstrates expert knowledge of a technical discipline and a working understanding of EMA and National Authority guidances.

Travel 10-15%

Qualifications:

Associate Director:
  • M.S. in a scientific discipline
  • 8-10 years pharmaceutical industry experience with 4+ years direct EU CMC regulatory experience or PhD. in a scientific discipline with 6-8 years pharmaceutical industry experience and 4+ years direct EU CMC regulatory experience
  • Recent experience in the support of successful submissions and approval of submissions in the EU through the Centralized, Mutual Recognition, and National procedures and in post-license variations.
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 EU CMC regulatory experience
  • Recent experience in the support of successful submissions and approval of submissions in the EU 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.