Director Regulatory Affairs CMC

Lundbeck•Deerfield, IL

6d•$225,000 - $255,000•Remote

About The Position

Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.

Requirements

Accredited bachelor's degree
Minimum of eight (8) years of experience in the Pharmaceutical, Biotech or Medical Device Industry with direct experience with small molecule/biologic technical functions.
Minimum of five (5) years of experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing.
Capability to interact with CMC technical experts regarding process development and analytical issues.
Demonstrated success in global submission filing, approval, and lifecycle management.
Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management.

Nice To Haves

Bachelor of Science or Arts Degree; life science related degree
Master or PhD of Science
Combination product (drug/device) experience

Responsibilities

Serves as regulatory CMC representative on development and marketed product teams.
Responsible for advising teams on regulatory authority expectations and guidelines and ensure the CMC regulatory strategy is in alignment with the global strategy and with the Target Product Profile.
Manage interactions with Health Authorities for assigned project(s) to ensure acceptance, rapid review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information.
Maintains an in-depth level of understanding of the company's compounds, their characteristics, manufacturing aspects and specifications/analytical methods.
Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected.
Coordinate preparation and review technical reports and CMC sections of global submissions to support clinical investigation and marketing applications.
Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships with CRO's or others who work on the company's behalf.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Support CMC QA functions, e.g deviations, general GMP/regulatory mixed topics.
Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise project teams accordingly.