Dir Regulatory Affairs CMC

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:

Effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of CMC Sections of all regulatory submissions and provide regulatory CMC support across all projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.

Responsibilities:

• Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communicates. Interact with FDA on submissions for CMC issues to ensure rapid preparation and approval of submissions and resolution of queries.
• Manages, prepares, and compiles well organized scientifically sound CMC related regulatory submissions to ensure completion within project timelines and to satisfy FDA requirements.
• Provides detailed risk assessments for regulatory submissions and works with the technical groups to assure successful implementation of mitigation measures
• Evaluates changes control for determination of submission type and regulatory documentation requirements. Prepares reviews and compiles supplemental submissions to assure timely FDA approval.
• Prepares CMC sections of INDs/NDAs, amendments, supplements and annual reports including the compilation and review of the required data, scientific reports and written submission contributions and ensures timely completion.
• Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy and proactively identifies CMC issues to pharmaceutical development and post marketing projects. Provides guidance to technical team members for the requirements and content of regulatory CMC documentation.
• Develops and implements the regulatory CMC project plan from IND to NDA and the post marketing phase to support submissions in the USA
• Interface with regulatory authorities at all appropriate stages of drug development to ensure the regulatory success of the company's CMC programs. Develop professional relationships with key regulators within those FDA Divisions with which the company interacts.

Qualifications

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

Education/Experience:

• BS degree in science, pharmacy or other scientific discipline. Graduate degree is preferred. Regulatory affairs certificate is desirable.
• 9-14 years of Pharmaceutical Industry experience including a minimum of 5 years of regulatory or related experience
• 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.
• 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, 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 and NDAs.
• Travel to domestic and international production sites and laboratories both company and contractor. Excellent oral and written communication skills with a focus on accuracy and clarity are essential to represent RACMC internally and with health authorities. Successful track record in the preparation of complex high-quality regulatory documents and manage the FDA review process.

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
Dir Regulatory Affairs CMC

City
Basking Ridge

Functional Area
Pharma Technology

State
New Jersey