Director Regulatory Affairs CMC

Location
Basking Ridge, New Jersey, United States
Posted
Jun 19, 2019
Ref
9662BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:

The incumbent leads a group with a focus on biological therapeutics.
Management responsibilities include 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 FDA and EMA interactions to include scheduling and leading meetings with FDA and EMA CMC staff, and preparation the company personnel for FDA and EMA interactions.

Responsibilities:

Management of Group
  • Manages the RA CMC group providing guidance on overall biologics 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 (e.g., FDA and EMA) for CMC issues to include pre-IND, EOP2, pre-NDA, Type B and C Meetings and Scientific Advice meetings; 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 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/IMPDs/Amendments/NDAs/ MAAs/BLAs 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 on CMC project sub-teams and RA project teams, and an ad hoc member to the global project team (GPT). 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 through maintenance of scientific knowledge for recombinant proteins, monoclonal antibodies, and antibody-drug conjugates. Maintains an expertise in 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 FDA and EMA. In addition, prepares CMC sections of annual reports and DSURs.

Qualifications:

Education and Experience:
  • M.S./PhD. in a scientific discipline 9-15 years pharmaceutical industry experience with a minimum of 5 years or Ph.D. in a scientific discipline with 8-10 years pharmaceutical industry experience and a minimum of 5 years direct or related CMC regulatory experience.
  • Successful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA


Competencies:
  • Advanced and comprehensive knowledge of regulations/guidance documents and corporate industry standards and an ability to evaluate same for impact on strategic plans and tactical operations. With strong scientific technical knowledge, provide committed value added effort in support of development and commercial projects.
  • Excellent oral and written communication skills; ability to manage multiple tasks with minimal supervision; strong organizational capabilities required. Ability to produce work to a high standard with attention to detail. Required to keep abreast of biologic CMC requirements for recombinant proteins, monoclonal antibodies and antibody-drug-conjugates.
  • Establish strong relationships with Corporate and Divisional Partners and regulatory Health authorities along with company stakeholders on a cross functional basis including Marketing, Legal, Technical CMC, Quality, Supply Chain, Clinical Regulatory to ensure perfect alignment and synchronization between Regulatory processes and strategic business goals.
  • Experienced in supervising, coaching, motivating, and mentoring junior staff members including effective work delegation.
  • Thorough understanding of the core processes of development, manufacturing and marketing. Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs/IMPDs and NDAs/MAAs/BLAs.


Job Title
Director Regulatory Affairs CMC

City
Basking Ridge

Functional Area
Pharma Technology

State
New Jersey