Manager, CMC Regulatory Dossier Management I - Alameda, CA

Orbis Clinical is seeking a Temporary Manager, CMC Regulatory Dossier Management I located in Alameda, CA for 12 months.

Job Title: Temporary Manager, CMC Regulatory Dossier Management I

Location: Alameda, CA

Contract: 12 months

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:

• 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.

Top Skills: 

• Strong background (3-5 years) in a technical field (CMC) in the pharma or biotech industry. Analytical chemistry & Development, QC Testing, Manufacturing Operations, Quality, Chemical Development, Biomanufacturing
• Experience with technical or regulatory writing. Writing SOP's, tech reports, any kind of regulatory documentation.
• Cross functional experience, strong communicator, will be working on documents with multiple contributors and approvers.
• Detail oriented experience with documents and systems. Advanced functions in Word, etc. Be able to use Style Sheets.
• Big plus is someone with familiarity with Regulatory Information Management systems (RIM). Veeva is the one company uses. Someone with the Veeva Regulatory module would be a top qualified candidate, any type of Veeva experience (Veeva Clinical, Medical, Commercial, Safety, etc) would be next, and then any other RIM would be great, Documentum is a popular one on the market.

Working Conditions:

PSC/Alameda:

• Environment: primarily working in office
• Travel not required

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $75.00 - $85.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.