CMC Regulatory Dossier Management (2 positions)

System One; Alameda (CA); On-site; USD 83,000 - 110,000; Full time

Job summary

System One, Inc. is seeking a CMC Regulatory Dossier Management consultant for a 1-year renewable contract in Alameda, CA.

The role requires hands-on experience with Regulatory Information Management systems and CMC submissions to health authorities, with on-site work Monday to Friday. Responsibilities include authoring, reviewing, and approving regulatory documentation, coordinating timelines with stakeholders, and ensuring compliant QC checks and archiving of source documents, while supporting

Qualifications

• BA/BS and 2-4 years of experience in medical/technical writing; or MS and 1 year of experience in technical (CMC) or regulatory writing.
• Minimum 5 years experience in the pharmaceutical or biotech industries.
• Possess Chemistry, Manufacturing and Controls (CMC) knowledge experience through the support of manufacturing operations in a technical or quality role.
• Familiarity with Common Technical Document content templates, as well as content expectations for IND/NDA/BLA/MAA or other regulatory documentation.
• Experience with electronic regulatory information management systems, such as Veeva, recommended.

Responsibilities

• Support the development of high quality, phase appropriate CMC-related submissions to health authorities by managing the authoring, review, and approval of regulatory documentation.
• Manage the document review process and schedule meetings to ensure documentation timelines are achieved, providing status updates as necessary to stakeholders.
• Manage the QC check of regulatory documentation by technical SMEs and ensure appropriate archiving of source technical documents.
• Facilitate domestic and global regulatory lifecycle submissions through the management of supporting technical and regulatory documentation requests with external partners and vendors.
• Ensure continued regulatory compliance and phase appropriate, risk-based approaches to manufacturing flexibility while adhering to change control procedures and health authority requirements.
• Contribute to the development and maintenance of the working practices and procedures, as well as help update and maintain procedures, templates and documents.

Skills

Regulatory writing

CMC knowledge

Education

Bachelor's degree in a related field

Tools

Veeva

Job description

Job Title: CMC Regulatory Dossier Management (2 positions) Location: Alameda, California Type: Contract (1-year, renewable) Work Model: On-Site (100%) Hours: 8am-5pm, m-f, fully onsite

Overview

Our pharma client is hiring a CMC Regulatory Dossier Management consultant for a 1 year renewable contract. This opportunity requires a candidate with strong Regulatory Information Management systems (RIM) experience.

Responsibilities

• Support the development of high quality, phase appropriate CMC-related submissions to health authorities by managing the authoring, review, and approval of regulatory documentation.
• Manage the document review process and schedule meetings to ensure documentation timelines are achieved, providing status updates as necessary to stakeholders.
• Manage the QC check of regulatory documentation by technical SMEs and ensure appropriate archiving of source technical documents.
• Facilitate domestic and global regulatory lifecycle submissions through the management of supporting technical and regulatory documentation requests with external partners and vendors.
• Ensure continued regulatory compliance and phase appropriate, risk-based approaches to manufacturing flexibility while adhering to change control procedures and health authority requirements.
• Contribute to the development and maintenance of the working practices and procedures, as well as help update and maintain procedures, templates and documents.

Requirements

• BA/BS and 2-4 years of experience in medical/technical writing; or MS and 1 years of experience in technical (CMC) or regulatory writing.
• Minimum 5 years experience in the pharmaceutical or biotech industries.
• Possess Chemistry, Manufacturing and Controls (CMC) knowledge experience through the support of manufacturing operations in a technical or quality role.
• Familiarity with Common Technical Document content templates, as well as content expectations for IND/NDA/BLA/MAA or other regulatory documentation.
• Experience with electronic regulatory information management systems, such as Veeva, recommended.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical