Manager, CMC Regulatory Dossier Management I

Planet Pharma Group; Alameda (CA); On-site; USD 99,000 - 113,000; Full time

Job summary

Planet Pharma is seeking a Manager, CMC Regulatory Dossier Management to convert scientific data into clear regulatory documents for global health authorities and stakeholders. The role focuses on authoring and managing Module 2/Module 3 CMC submissions, technical reports, and SOPs.

The ideal candidate has 5+ years in pharma/biotech, CMC knowledge, and experience with regulatory information management systems like Veeva. Office-based in Alameda, CA with no travel required.

Qualifications

• 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.
• CMC knowledge through support of manufacturing operations in a technical or quality role.
• Familiarity with Common Technical Document content templates and content expectations for regulatory submissions.
• Experience with electronic regulatory information management systems, such as Veeva.

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

CMC knowledge

CTD templates

Regulatory writing

Veeva experience

Education

BA/BS in medical/technical writing

MS in technical (CMC) or regulatory writing

Tools

Veeva

Job description

Target PR Range: 72-82/hr DOE

SUMMARY/JOB PURPOSE:

The Manager, CMC Regulatory Dossier Management is responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical and regulatory documents intended for global health authorities and internal/external stakeholders. The job scope is focused on authoring and managing the review and approval of moderate to complex CMC regulatory documents, including but not limited to Module 2 and Module 3 CMC regulatory submissions for development and post-approval dossiers, technical reports and SOPs.

ESSENTIAL DUTIES AND 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.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• 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.

Experience/The Ideal Candidate will have:

• Minimum 5 years experience in the pharmaceutical or biotech industries.

Knowledge/Skills:

• 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.

WORKING CONDITIONS:

PSC/Alameda:

• Environment: primarily working in office
• Travel not required