Daiichi Sankyo Inc. Director Regulatory Operations - Dossier Planning in Basking Ridge, New Jersey
Auto req ID 8474BR
Job Title Director Regulatory Operations - Dossier Planning
Functional Area Research & Development
City Basking Ridge
State New Jersey
Job Description IMPORTANT NOTE: We are very pleased to announce the location of Daiichi Sankyo, Inc.’s new US headquarters where our Parsippany- and Edison-based teams will be co-located in a combined site in early to mid-2017. Our new headquarters will be in Basking Ridge, New Jersey at 211 Mt. Airy Road.
The role of the Director, Dossier Planning, Regulatory Operations will primarily be responsible for managing the planning and delivery of regulatory submissions (IND, NDA, Agency Responses, others) required to support the development and registration of new products for worldwide customers.
This will be demonstrated by leading regionally focused Submission teams while directing the creation of the dossier and ensuring that all aspects of the plan are coordinated and executed efficiently.
Additionally, the Dossier Manager will be expected to provide guidance to project teams regarding document standards and processes, as well as interface with clinical, pre-clinical, CMC and other key contributors throughout the Company (as required) to resolve various submission issues.
Position leads dossier process standards, planning, electronic assembly, publishing, production, dispatch, and archive of regulatory submissions. This position provides supervision, strategic alignment, management, job training, and leadership for a team of RO professional. This position may represent DS on industry related external committees.. This position acts as a functional lead in representing Regulatory Operations externally to other functions within Daiichi Sankyo as well as outside of Daiichi Sankyo and builds cross-functional relationships to improve efficiency, sustainability, and the progression of business objectives. Additionally, this position supports forecasting of vendor costs and other budget related items. This position works often with ambiguity and complex problems and can make day-to-day submission decisions without prior approval. This position also demonstrates general proficiency in process excellence and planning, a high level of Regulatory knowledge, and an understanding of regulatory publishing and electronic document management processes. Additionally, this position possesses an advanced knowledge of the drug development processes, relative functional capabilities, and interdependencies. This position demonstrates an advanced ability to manage a planning group with experience in dossier planning. Finally, this position manages across a sub-function and works with project teams to determine the global strategy for application filing.
Technology: Selects the appropriate technology and vendors to deliver and support solutions and requirements for the changing landscape of submissions. Supports and understands the impact of standards and requirements. Executes the strategic roadmap of aligning systems with a global impact. Responsible for regulatory submission process improvements and establishing repeatable processes utilizing key technologies. Creates and maintains submission timelines using planning tool/software.
Strategy and Initiatives: Provides input on optimal submission strategy for the company. Leads and actively engages external and internal initiatives. Leads communications with external partners and health authorities. Advises on submission strategy and takes part in project team meetings. Assists in the writing of departmental SOPs.
People: Advises others within Regulatory as well as various associated departments. Provides leadership and manages Global Submission or Dossier Planning function. Leads and oversees the strategic implementation of outsourcing services were applicable. Leads Submission Team meetings
Submission Team Leadership/Group Facilitation: Drives strategic and tactical decisions regarding regulatory filings. Responsible for timely submission of high quality regulatory submissions in all formats. Manages the submission process from initiation through to approval and dispatch for major Regulatory submissions (IND, NDA, Agency Responses, others). Supervises managers who will oversee the day-to-day submission activities and or Dossier Team for global project. Manages and leads a highly trained and skilled team. Develops individual career development path and assists team members with their own development. Provides guidance/training to the Submission Teams on internal document submission standards and processes
BS or MS degree in Life Sciences is required
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.