Why Regulatory Affairs at Millennium?
Regulatory professionals at Millennium support all of our development compounds from discovery through commercialization. Since Millennium’s drug development starts early in the pre-IND phase through to key milestones and onto registration and developing the label for global distribution, regulatory professionals at Millennium play a vital role in developing and delivering medications to patients around the world. The exciting growth of the Millennium pipeline - both in best-in-class and first-in-class compounds - is fueling the growth of our Regulatory Affairs department and the number of late stage compounds within our pipeline. At Millennium, our regulatory professionals have the satisfaction of translating what happens at the bench and seeing those discoveries realized to create beneficial therapies for our patients worldwide.
Our Mission, Our Culture
Millennium aspires to cure cancer and is looking for dedicated people to join our Regulatory Team who are passionate about this mission. Our Regulatory professionals work within a supportive and collaborative culture. In our unique structure, Regulatory professionals work on teams with our scientists; allowing them to be involved in the Regulatory process and also to understand the science of the product they are helping to develop. Millennium offers great career development opportunities for new and existing employees, which includes a formal development plan, supported by management, where employees identify appropriate activities to advance their careers.
Departments Within Regulatory Affairs at Millennium
Regulatory Affairs at Millennium: The Takeda Oncology Company touches all aspects of our pipeline and consists of five key departments that ensure compliance at every phase of the development, approval and marketing process.The Regulatory Therapeutics department develops global regulatory strategies to gain competitive advantages for our products. Regulatory professionals within this department provide strategic regulatory representation on cross-functional teams to ensure successful global development strategies and filings. They also serve as the primary liaison in interactions with the FDA and Health Canada, leading key scientific and submission strategy discussions, as well as provide strategic support in interactions with other regulatory agencies.
Regulatory Chemistry, Manufacturing and Controls (CMC):
The Regulatory CMC department develops regulatory strategies to gain competitive advantages for our products, supporting a product from a CMC perspective over its entire lifetime (early development to post marketing). Regulatory professionals within this department provide regulatory strategy and guidance to project teams pertaining to all aspects of drug substance and drug product development activities. They also act as the primary liaison with Health Authorities for CMC issues. Regulatory Labeling & Promotion:
The Regulatory Labeling & Promotions department directs all regulatory aspects for labeling and promotion of medicinal products, ensuring awareness of evolving U.S./International regulatory initiatives that apply to labeling and promotional compliance. Regulatory professionals within this department work closely with the Promotional Materials Review Team (PMRT) to review and approve all advertising and promotional pieces for regulatory compliance. Regulatory International:
The Regulatory International department is positioned in the U.S. and formulates the overall regulatory strategy to support product development and approval efforts for all pre- and post-marketing projects in non-US countries. Regulatory professionals in this department serve as the primary liaisons with international CROs, other Takeda organizations, and with all Health Authorities outside of the U.S. and Canada. They also work with Millennium’s international colleagues to understand evolving international practices and requirements and facilitate effective communication of these issues to the product development teams. Regulatory Operations:
Overall, the Regulatory Operations department leads, with Medical Informatics and Information Management (MIIM), the implementation, deployment and maintenance of submission-related information technology systems (NexDoc, eCTD, Insight Publisher, mTRACK). Within Regulatory Operations are three groups: the Dossier Management Group which leads and manages regulatory submissions, develops timelines, and manages message development and the overall authoring and review processes; the Regulatory Compliance group which is responsible for all compliance related activities in Regulatory Affairs; and the Submission Operations Group which prepares, submits, maintains and manages the lifecycle of regulatory dossiers, both paper and electronic, to worldwide health authorities.