Director, Regulatory Affairs, CMC

Job Description
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Join a growing biopharma company focused on Oncology
Great opportunity to oversee a team changing the lives of cancer patients

About Our Client

Biopharmaceutical company focused on developing medicines to improve survival and quality of life of cancer patients. Their portfolio consists of small molecule inhibitors that promote cancer cell survival and tumor growth.

Job Description

This position requires knowledge of U.S. Federal Regulations related to GMP requirements (21 CFR 210, 211) ICH guidelines, and a familiarity with GLP and GCP requirements and guidelines clinical research (21 CFR Parts 50, 56, 312)

Leads the preparation and review of CMC sections of regulatory submissions, as well as the communication plans with regulatory agencies.
Leads development of global CMC regulatory strategies and submissions.
Provides CMC regulatory guidance to cross-functional teams and key stakeholders.
Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects.
Preparation and submission of INDs, IND amendments, NDAs, BLAs and other regulatory submissions, as required. Coordinate with Technical Operations, Supply Chain, Clinical Operations, and other groups to assure timely and accurate preparation of regulatory submissions.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Minimum of a Master's degree or equivalent in Regulatory Affairs or a closely related scientific discipline.
10 plus years of Regulatory Affairs experience in the biopharmaceutical industry with a focus in CMC topics.
Experience is in the therapeutic area of oncology is required..
Additional experience working with one or more of the expedited programs being offered by FDA, Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval or priority review as well as the Real Time Oncology Review pilot program is preferred.
Knowledge of Veeva RIM preferred.