Director Head of CMC Regulatory Affairs

Profile

What We Do

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Theragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state of the art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.

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Why Theragent?

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Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives.

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Our Mission:

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To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.

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Position Summary:

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The Director and Head of CMC Regulatory Affairs leads the successful operation of the Regulatory Affairs (RA) business functions at Theragent through interaction with internal leaders and external clients. The incumbent in this role, reporting directly to the Chief Operating Officer and the executive leadership team, executes the RA Game Plan and identifies the opportunities for growth and development of the department while maintaining RA services to the Theragent clients. This individual supports the manufacturing and Quality operation team and works collaboratively with the executive leadership team including leaders from IT, MSAT, Facility Services, and Process Sciences.

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As a key department leader in the organization, this position will directly interface with Theragent’s clients to assist and consult on efficient and complete Regulatory Strategies and serve as Theragent’s front line communication to the Global Regulatory agencies. This position will be a significant contributor to the client’s successful process and manufactured product by offering specific industry experience regarding the CMC Regulatory requirements.

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The Director and Head of CMC Regulatory Affairs will act as the CMC regulatory representative to develop CMC regulatory strategies, submissions, and compliance activities for Theragent and Theragent’s CDMO clients.

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Key Responsibilities

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·Provides strategic guidance on FDA and global CMC regulatory requirements for investigational and commercial products.

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·Compiles, writes, reviews, and approves CMC modules of development and marketing registration applications, amendments, and supplements for submission.

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·Develops and implements CMC regulatory strategies for the earliest possible product approval.

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·Assists with preparation and lead meetings with Health Authorities.

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·Manages and ensures compliance with all reporting requirements, including annual and periodic reports when applicable.

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·Serves as CMC regulatory lead at internal meetings as well as at meetings with business partners, CDMO Clients, and regulatory agencies for all CMC related issues.

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·Assesses and communicates CMC regulatory requirements to ensure all development activities are following applicable regulations and guidelines.

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·Leads and assists in the preparation of Policies, Standard Operating Procedures and Work Instructions.

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·Mentors and develops regulatory talent within the regulatory department.

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·Other duties as assigned.

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Professional Experience/Qualifications

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· 10 years of experience in Regulatory Affairs related to the development of pharmaceuticals with a minimum of 5 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, Oncology cell and gene therapy experience is a must.

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·Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.

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·Experience in working directly with key regulatory agencies (FDA, EMA).

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·Demonstrated experience in CMC in bringing developmental assets to commercial stage.

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·Established working knowledge of regulatory guidelines and regulations (US and international).

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·Regulatory experience supporting both development projects and marketed products.

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·Strong knowledge of eCTD elements and structure and regulatory writing skills.

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·Prior experience with IND/NDA/BLA submission is strongly preferred.

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* This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities and activities may change at any time with or without notice.

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*Theragent Inc is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.

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**MEMBERS ONLY**SIGN UP NOW***. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.

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