Sr. Manager, Regulatory Operations – Boston

Company Information:

Breakthrough Careers!
A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

Responsible for leading the Submission Operations group in Regulatory Operations. Responsible for managing all staff directly involved in submission publishing and archiving. Reports directly to the Sr. Director of Regulatory Operations. Plays leadership role in establishment of Electronic Common Technical Document (eCTD) capability.

Duties and Responsibilities:

As leader of the Submission Operations group:

Responsible for publishing and archiving of both paper and electronic regulatory submissions, the processing of expedited safety reports and document retrieval.

Responsible for managing external vendors which support the activities of the group.

Responsible for managing Regulatory Operations' high-volume printer and scanner.

Responsible for maintaining a forward-looking master publishing schedule of all upcoming submissions, and effectively managing department resource to assure timely preparation and delivery of all regulatory submissions.

Responsible for implementation of the Electronic Common Technical Document (eCTD) capability at Millennium.

Responsible for supporting Regulatory Affairs department operations, such as budgeting and resource management.

Responsible for implementing and maintaining consistent Submission Operations processes.

Qualifications:

Minimum of 3+ years publishing experience
Strong detail orientiation
Experience implementing new processes and procedures
Electronic submission experience
Expertise in Word, Excel, Powerpoint
Strong collaboration skills
Strong project management skills
Previous supervisory experience

Highly desirable:
eCTD experience


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