RCM Technologies Director, Regulatory CMC in Waltham, Massachusetts
Reference # :21-00144Title :Director, Regulatory CMCLocation :Waltham, MAPosition Type :Direct PlacementExperience Level :Start Date :03/01/2021 DescriptionThe OpportunityOur Client is in search of an experienced and highly motivated team-player to join our growing Regulatory Affairs department. This individual will be responsible for preparing CMC and Quality related agency correspondence and regulatory applications to support our global oncology clinical trial programs.This is a great opportunity to lead REG-CMC development of early and late-stage assets and address the regulatory challenges associated with an investigational product that has both biologic and small molecule components. Reporting to the Sr. Director, REG-CMC this individual will define the global RA-CMC strategy and requirements for marketing applications for an antibody-drug conjugate that was granted Breakthrough Designation last year by FDA. Additional responsibilities will include the oversight of one or more early-stage programs (IND/IMPD development and maintenance). This individual will serve as lead at FDA and Scientific Advice CMC meetings and direct the preparation of the associated briefing packages.Responsibilities:
Develops effective CMC regulatory strategies for submissions (e.g., IND/CTA/BLA/MAA) and identifies potential regulatory risks.
Manages regulatory CMC aspects of product development projects.
Ensures the timely preparation and submission of initial INDs, CTAs, amendments, and market applications.
Coordinates responses to questions from health authorities.
Provides regulatory evaluation of CMC change controls.
Represents Regulatory CMC in interdisciplinary teams (specifications/stability/change review) and project teams.
Provides interpretation of regulatory guidance documents, regulations, and directives; and advises Manufacturing, Process, and Analytical Development and QA groups regarding their applicability and impact on internal programs.
Provides input on CMC topics to licensing partners.
Communicates critical topics to the appropriate management level.
Who You AreMinimum BS in a scientific discipline, advanced degree preferred
At least 10 years of experience in regulatory in the pharmaceutical/biotech industry, including authorship of CMC/Module 3 regulatory submissions in the US, Europe, and Canada.
Experience with participating in or leading health authority meetings.
Late-stage development experience with well-characterized biologics (such as antibodies) preferred.
Strong knowledge of current US and EU regulations and guidances, Good Manufacturing practices (cGMP)
Ability to effectively organize and prioritize tasks to achieve established deadlines.
Strong verbal and written communication skills.
Strong general technology skills.
Strong project and submission management skills.
Ability to work effectively through cross-functional team to achieve results.
RCMTechnologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.