Position leads 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 professionals. 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 an operations group with experience in planning in a regulatory-based function as well. Finally, this position manages across a sub-function and works with project teams to determine the global strategy for application filing.
1. 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
2. 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
3. People: Advises others within Regulatory as well as various associated departments. Provides leadership and manages Global Submission Operations function. Leads and oversees the strategic implementation of outsourcing services
4. 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. 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
- BS or MSdegree 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.