Manager, CMC Regulatory Dossier Management

Manager, CMC Regulatory Dossier Management I

Pay Rate: $80.00-$84.04/hr., depending on experience

Location: Alameda, California 94502 (Fully onsite)

Duration: 12 Months

Shift: 8am-5pm, m-f, fully onsite

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.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.