Associate Director/Director, Regulatory Operations in Bernards, NJ at DSI

Date Posted: 8/23/2018

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

Position is responsible for process standards, planning, publishing, production, dispatch, and archive of regulatory submissions. This position ensures SOP adherence, application of best practices, oversight of CRO, and customer interactions. The position works in ambiguity with complex problems and defines directions with limited direct supervisor oversight. Additionally, this position demonstrates expert Regulatory publishing skills, a general proficiency in Process Excellence and planning, and expert working knowledge of electronic document management practices and related technologies. He/she will support the implementation and integration of the Regulatory Information Management (RIM) system into current business practices and participate in all regulatory operations activities. This position possesses an expert understanding and working knowledge of global submission format requirements and a strong knowledge of the drug development processes, relative functional capabilities, and interdependencies. This position demonstrates an advanced ability to manage an operations group with experience in submission coordination. This position will provide oversight to Labeling Operational activities including maintenance of data input to regulatory databases and tracking spreadsheets, and preparation and review of Structured Product Labeling preparation via external vendor and internal Labeling Group. This position will support all relevant annual user and site fee registration processes. Finally, this position manages across a sub-function and works with project teams to determine the global strategy for application filing.

Responsibilities

Technology: Selects the appropriate technology and vendors to deliver and support solutions and requirements for the changing landscape of submissions. Understands the impact of standards and requirements. Executes the strategic roadmap of aligning systems with a global impact. Identifies regulatory submission process improvements and establishing repeatable processes utilizing key technologies. Facilitates implementation and integration of RIM into current business practices

Strategy and Initiatives: Provides input on optimal submission strategy for the company. Actively engages in internal/external initiatives. Supports communications with external partners and health authorities. Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH regulations. Participate in the development and implementation of standards, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation and conduct associated trainings; recommend and help implement associated process improvements.

People: Collaborates with others within Regulatory as well as various associated departments. Provides leadership and manages Global Submission Operations function. Oversees the strategic implementation of outsourcing services. Leads assigned projects with manageable risks and resource requirements, driving and managing the operational development, publishing, production and archiving of submissions and/or submission components and ensuring high quality regulatory document deliverables

Submission Team Leadership/Group Facilitation: Drives tactical decisions regarding regulatory filings. Responsible for timely submission of high quality regulatory submissions in all formats. Supervises managers who will oversee the day-to-day submission activities. Manages and leads a highly trained and skilled team. Develops individual career development path and assists team members with their own development and collaborates with external service providers in support of DS priorities

Qualifications

Education and Experience
  • BS or MS degree in Life Sciences is required
  • Associate Director: Experience in the pharmaceutical industry with 7-10 years of direct regulatory operations experience
  • Director: Experience in the pharmaceutical industry with 10+ years of direct regulatory operations experience
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.