Director, RACMC Portfolio Products - Biologics

Location
Basking Ridge, New Jersey, United States
Posted
Sep 16, 2020
Ref
10191BR
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
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:

The Director, RACMC Portfolio Products, provides regulatory CMC (Chemistry, Manufacturing, and Controls) leadership for the portfolio BLAs and is responsible for the life-cycle management of biological drugs. The incumbent develops optimal CMC submission strategies and mitigation plans in order to obtain the shortest approval time by the FDA and Health Canada. Responsible for preparation, review and final approval of CMC documentation to regulatory agencies. Candidate represents the regulatory function on multi-disciplinary CMC/technical teams and interacts with external entities. Will also provide regulatory CMC guidance to ensure life cycle management activities are compliant with relevant regulations and update management as needed. Initiates or contributes to local and /or global process improvements which have significant impact on business. Will serve as direct liaison to the FDA and participate in FDA meetings. Candidate will have management responsibilities.

Responsibilities:
  • Supports CMC regulatory compliance activities for biological portfolio products to meet US, Canada, International Conference on Harmonization (ICH), and other applicable regulations. This includes preparation and/or review and approval of CMC documentation for BLA Annual reports, Lot Distribution Reports and Biological Product Deviation Reports. Ensures that CMC documentation is complete, well organized, scientifically and technically sound, of a high quality, aligned with the current regulations, and presented in a manner that facilitates Health Authority reviews.
  • Supports company`s GMP Change Management Program. Evaluates CMC changes to biological portfolio products and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation. Makes CMC regulatory decisions, balancing risks and benefits. Coordinates with local/global RACMC, Quality Assurance, Pharmaceutical Technology and other functional areas to secure approval for CMC changes and assess regulatory implications. Prepares and /or reviews CMC documentation for supplemental BLA applications.
  • Acts as a point of contact with regulatory agencies. Negotiates with FDA and Health Canada, as needed, for all aspects pertaining to CMC of the biological portfolio products including resolution of key CMC regulatory and lifecycle management issues and securing expeditious approvals of post- changed drug products. Leads meetings with regulatory agencies. Prepares internal teams for these interactions to build strong relationships with FDA/Health Canada and secure successful meeting outcomes. Coordinates preparation/review and finalization of FDA/Health Canada meeting materials to include briefing books and meeting minutes.
  • Works with heightened cross functional expertise in a matrixed environment with various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain & Technical Operations, Pharmaceutical Technology and others where applicable. Identifies areas for process /procedure improvements and works on improvement implementation. Promotes development and implementation of emerging technologies which have constructive impact on business. Provides training on evolving regulations.
  • Plans, assigns and directs work for staff and manages competing priorities as appropriate.
  • Must be able to travel approximately 20%.

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

Education/Experience:

Bachelor`s degree required. Master`s degree in Life Sciences or Ph. D preferred.

10+ years in pharmaceutical industry experience with 7+ years direct CMC regulatory experience working with biologics. Prior employment with FDA preferred. Demonstrated ability to develop robust regulatory CMC plans covering post approval drug products. Proven track record of supporting successful regulatory strategies and approvals of BLAs with least burdensome regulatory approaches. Abilities to advise stakeholders on RACMC strategies and provide training where applicable.

Extensive knowledge of US and ICH-CMC regulatory requirements for biological drugs and ability to apply knowledge both strategically and operationally to marketed drug products to resolve regulatory issues. Must have a thorough knowledge and extensive successful experience with Technology Transfers, Established Conditions, Comparability Studies, Risk Assessment Studies, Stability Studies and post approval change management.

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
Director, RACMC Portfolio Products - Biologics

City
Basking Ridge

Functional Area
Supply Chain

State
New Jersey