Director/Senior Director, Regulatory Affairs CMC
Posted on Apr 5, 2021 by CytomX Therapeutics, Inc.
As Director, Regulatory Affairs CMC, you will be responsible for developing, leading, and implementing global regulatory CMC strategies for assigned assets within CytomX's Probody portfolio and in coordination with key internal stakeholders. This position will lead and manage regulatory CMC aspects through all phases of development (IND filing through approval), post-approval, and life-cycle of the product.
Primary responsibilities will be in creating CMC regulatory strategies for development programs in preparation and maintenance of regulatory applications.
You will be a key member of the Regulatory team and a leader within the CytomX community. This is a hands-on position in which you will partner with the VP Regulatory as well as co-workers, team leaders, functional leads, and management to:
Serve as the regulatory CMC representative on project teams.
Provide CMC regulatory support and guidance for assigned projects and interface with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
Develop and implement effective regulatory CMC timelines and strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and interpret and apply local regulations and guidance to the life cycle of a drug product.
Manage/prepare CMC document packages for regulatory submissions in support of development programs. This includes initial submission of INDs, CTAs and amendments to Health Authorities (HAs), and preparation of responses to questions from HAs balancing HA requirements and corporate objectives.
Manage timelines in cooperation with Project Management on assigned projects and submissions.
Review technical reports and write CMC sections of IND, CTA, BLA, MAA, and other global submissions to support clinical trials and marketing applications, and their amendments in conformance with regulatory requirements, strategies and commitments.
Work with regulatory CROs to identify regional/country-specific CMC requirements to support global applications.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide strategic regulatory guidance for optimal implementation of changes.
Actively participate as a member of global regulatory teams and CMC subteams.
Support and manage regulatory aspects of CMC Operations including authoring, reviewing and and/or approving SOP's, CAPA's, etc.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
Key representative on Change Control Review Board (CCRB) Key Regulatory Representative.
Author/review Annual Product Review
Provide strategic input on Global Manufacturing & Supply Chain Optimization
Where appropriate, supervise and lead internal staff and/or negotiate and oversee work performed by contractors
Educational background in life sciences is required;
Preferred advanced scientific degree, eg MS PhD, MD, JD.
The candidate should have at least 10 years of indirect Regulatory experience within the context of a biopharmaceutical company
Minimum 7 years of direct experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in product lifecycle management from Phase 1 through commercial and post-approval. Knowledge/experience with Antibody-Drug Conjugates is desired.
Expertise in commercial product lifecycle as well as Phase 1-3.
Prior success in filing IMPDs, marketing applications, supplements, or variations for biologic products within timelines is required, global submission experience desired.
A good understanding of IND, CTA, BLA and MAA processes.
Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
An accomplished professional with excellent skills in team leadership and problem solving with regard to regulatory issues.
Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities.
Demonstrated ability to coach, train, and mentor teams.
Strong negotiating skills and ability to think creatively and develop creative solutions.
Ability to prioritize and handle multiple projects simultaneously.
Strength with planning and organizing to accomplish goals and deliverables- able to prioritize work activities, use time efficiently, completes tasks correctly, with a quality product and on time;
Follows instructions and responds to management direction.
Excellent Communicator - listens and seeks clarification; responds well to questions; Speaks clearly and persuasively in positive or negative situations; writes clearly and informatively; applies feedback to improve performance;
Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyones efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.
Delivers high quality work product- demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Computer Skills: Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), GANT charting with timelines desired.
Travel for Work: Must be willing to travel approximately 10-20%
Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability, and Fun
A highly accomplished individual who thrives on working in a collaborative environment.
Strong interpersonal skills are necessary.
A proven ability to communicate cross-functionally in a fast-paced environment is crucial.