Director, Regulatory Affairs & CMC

Location
Basking Ridge, New Jersey, United States
Posted
Aug 28, 2020
Ref
10451BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The incumbent leads and manages a group of regulatory professionals.

This position is responsible for providing expert CMC regulatory and biological technical guidance on developments, and expert scientific advice on the solution of technical developmental issues within projects from a CMC regulatory perspective; management review of submissions for accuracy, quality and regulatory compliance.

Project responsibilities include membership on the CMC project teams and RA project teams, and an ad hoc member to Global Project Team (GPT) and other functional teams; preparation of health authority submissions for both marketed and developmental products; representation of Daiichi Sankyo in Health Authority interactions to include scheduling and leading meetings with Health Authority CMC staff, and preparation the company personnel for Health Authority interactions. This position requires low level of supervision.

Responsibilities:

Management of Group
Manages the RA CMC group providing guidance on overall development strategy and expert CMC regulatory and technical advice on developmental issues within projects. Provides for management review of submissions for accuracy, quality and regulatory compliance.

Health Authority Interaction
For assigned projects, leads all aspects of the CMC health authority meetings to include: serving as the primary company liaison for interactions with regulatory health authorities for CMC issues; identifies critical issues with the development team for discussion with the health authority; leads the preparation, review and finalization of the briefing books; prepares the development team for the health authority meeting; leads the health authority meeting; leads the preparation and finalization of the meeting minutes.

Development Project Assignments
Develops strategy and provides the submission content template to the development team prior to major submissions and leads the development team in the preparation of the CMC regulatory submissions-i.e., INDs/Amendments/NDAs/ MAAs/BLAs/ Supplements, and DMFs to include scientific and regulatory review for accuracy, soundness and regulatory appropriateness. Authors regulatory/technical documents in support of regulatory submissions, where necessary. Supports clinical trials through review of Investigator Brochure, Pharmacy Manual and clinical supply labeling. Assures regulatory submissions are completed within the project timeline. For major submission, coordinates the preparation of the detailed risk assessment and works with the technical groups to assure successful implementation of mitigation measures. For health authority queries during the review, manages the responses by providing the tracking list to include regulatory recommendations, assignment of authorship, and task completion dates. Assures completion and timely submissions to all health authority queries.

Committee Assignments
Serves as RA CMC representative at cross-functional initiatives within DSI or with DST/DSI. Represents RA CMC on due-diligence in-license opportunities, pre-approval inspections, and support of ICH/PhRMA/EFPIA/USP initiatives.

Subject Matter Expert
Serves as the regulatory CMC expert to project team for the solution of complex technical issues based upon expert scientific knowledge and experience in past regulatory precedent. Maintains an expertise in areas focusing on molecular genetics and cloning techniques, characterization and purification of biologic products, biological product manufacturing processes to include fermentation, purification chromatographies (size exclusion, CEX, AEX), viral clearance methodologies, sterilization processes, lyophilization and companion diagnostic kit development.

Marketed Products
Evaluates change controls for determination of submission type and regulatory document requirements. Prepares, authors where necessary, reviews and compiles supplements/variations to assure timely approval by Health Authorities. In addition, assure the timely delivery of CMC sections of annual reports and DSURs.

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

Education/Experience:
  • M.S. in a scientific discipline 10-15 years pharmaceutical industry experience with a minimum of 8 years direct or related CMC regulatory experience, or PhD. in a scientific discipline with 8-12 years pharmaceutical industry experience and a minimum of 8 years direct or related CMC regulatory experience.
  • Successful track record in preparation, management of review and approval of NDA/BLA with Health Authority.
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, Regulatory Affairs & CMC

City
Basking Ridge

Functional Area
Pharma Technology

State
New Jersey