Senior Director, RACMC Portfolio Products in Basking Ridge, New Jersey at DSI

Date Posted: 6/20/2019

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:

The Senior Director, RACMC Portfolio Products will be responsible for leading the RACMC post-approval and local DSUSB team in developing and implementing CMC regulatory strategies for late life cycle products, line extensions, marketed and transferred products to secure and maintain market access for products in line with DSUSB objectives. This individual will define CMC regulatory submission strategies, plans and direct the filing of CMC submissions for U.S. post approval applications. This position will liaise with regulatory authorities, train and rehearse technical team and participate in regulatory meetings on CMC topics. This position will also conduct regulatory risk assessments and identify and recommend viable options.

Responsibilities:
Develop and Execute Strategy
  • Proactively provides and drives strategic and operational RA CMC direction for line extensions, local and in-licensing products. This would include general RACMC strategy development plans, and risk assessments, critical issue management and regulatory agency interactions and negotiations. Communicates and manages these regulatory measures and immediate actions required to prevent issues from jeopardizing DSUSB products.
Advise Leadership
  • Advise DSUSB leadership on CMC RA robust project strategies, risk assessments and viable options to support all DSUSB products to optimize approvals of regulatory submissions. Understand regulatory and commercial goals and design strategies and communications plans to address these goals. Proactively identify opportunities of project advancement and appropriately escalate issues. Work with DS leadership on CMC development, regulatory CMC registration strategies for post approval of DSUSB in-licensed products. Develop cost effective registration pathways to bring pre-change, post-change and DSUSB in-licensed local products to market in a timely and highly compliant manner.
Liaise and Negotiate with U.S. Regulatory Agencies
  • Have a forward “face” to FDA for contact and communication, participating in regulatory meetings and addressing CMC regulatory issues for post-approval and DSUSB in-licensed products. Ensures that marketed products are supported with minimal questions and CMC issues from regulatory agencies. Negotiates with the agency leading to optimal regulatory outcomes for DSUSB products. Leads training and preparing of technical project teams for FDA meetings. Designs and establishes well defined regulatory pathways and to create accurate and high-quality documents for post-approval regulatory submission and final approval. Proactively manages critical CMC issues, taking leadership for the regulatory contribution.
Develop and Manage the RA CMC Processes within DSUSB
  • Pioneer the development, innovation productivity and optimization of RA CMC processes, service relationships and performance to enable high quality RA CMC outputs. Enable portfolio excellence across DSUSB products. Build and maintain strong partnering relationships with other DS groups
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Qualified candidates must have a MS degree in Life Sciences from an accredited college or university; Regulatory Affairs Certification a definite plus. 10+ years of Pharmaceutical Industry experience in small molecules and biologics with strong emphasis of Production, Supply Chain, Commercial operations and/or Pharmaceutical Technology. At least 6 years of executive management level experience within RACMC.
  • Extensive experience in RAMC leading all types of submission documents, lifecycle management project, interaction and strategic negotiations with regulatory agencies, and developing and implementing complex CMC regulatory strategies. Proven track record success with NDAs/BLAs is required; experience with FDA interactions; comprehensive knowledge of the CMC lifecycle and line extension management processes; CMC related guidance and ICH related guidelines. Uses extensive knowledge of US and ICH regulatory requirements with the application of strategic and operational knowledge and regulatory pathways to projects for seamless transfer to DS-US business
  • Well-developed leadership and strong project management skills including demonstrated cross functional communication and accountability, interpersonal and influence management skills. Proactively creates, develops and positively influences the performance of team members with respect to strategic negotiations, and strategy/risk assessments. Develops team members through motivational leadership, exposure, stretch assignments and feedback.
Ability to travel up to 20%

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.