Manager/Senior Manager, CMC Technical Regulatory Writer

Manager/Senior Manager, CMC Technical Regulatory Writer

Remote - United States (East Coast)

Seeking experienced and motivated talent to be responsible for ensuring thorough preparation of drafts and templates, and the maintenance of Chemistry, Manufacturing, and Controls (CMC) content for global regulatory filings. In search of a quality, detail-oriented, regulatory CMC Technical Writer to deliver timely and efficient submissions of regulatory documents which will be key for this individual to succeed in this role. This is an individual contributor role to start and will collaborate with the Regulatory CMC Lead and other cross-functional department colleagues & other partners to ensure successful execution of all CMC activities are supported in the development of new and existing projects, and, in line with the company's business strategies and objectives.

Primary Responsibilities:

• Provides support for the preparation of CMC content and responsible for all CMC-related activities for global regulatory filings, i.e.: IND, IMPD, NDAs, BLAs, MAAs
• Assists in developing, authoring, analyzing, and the interpretation of CMC-related technical data (from SOPs, Batch Records, Reports, etc.) to authoring INDs and IMPD sections, module 2 summaries (QOS), briefing documents, and other documents needed to support regulatory interactions and filings for CMC.
• Reviews and supports Regulatory CMC Lead in responding to requests for information from regulatory agencies, as required.
• Assists in the development of standard operating procedures, work instructions/guidelines, templates, style and content guides, and document quality control for technical writing to ensure consistent preparation of high-quality technical documents.
• Performs literature searches/reviews as necessary to obtain background information for the development of documents.
• Performs quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
• Drafts CMC content for global regulatory filings for the review and approval of documents needed for regulatory filings.
• Independently manages all timelines and ensures all document-specific timelines are met to guarantee on-time deliverables are completed.
• Provides support and assists with discovering disparities between filing drafts and supporting CMC documentation with other team members to close known disparities.

Requirements:

• Bachelor's degree in a life science-related discipline is required.
• Demonstrated CMC technical writing skills with a minimum of 3 years of biopharmaceutical industry experience in pharmaceutical manufacturing or development and regulatory submissions is required.
• Biologics experience is an absolute requirement.
• Experienced in authoring documents for regulatory review with FDA and EMA.
• A thorough knowledge and direct experience authoring CMC sections of INDs, IMPDs, BLAs, MAAs (to include writing Modules 2 and Module 3 regulatory documents)
• Proven track record of delivering high quality work to tight deadlines.
• A solid understanding of the drug development process, including documents that are required at each stage and the regulatory environment, such as FDA/EMA/ICH.
• Previous experience with expert knowledge of cGMP guidelines is essential.
• Excellent writing skills coupled with the ability to edit complex material to ensure accuracy, clarity, and effectiveness.
• Excellent attention to detail, communication, time management, organizational skills, and flexible attitude with respect to work assignments and new learning with proven ability to interact in a team environment.
• Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides, and templates, in addition to Adobe Acrobat.

Preferred Qualifications:

• Advanced degrees in a related life science discipline.
• Experience in Cell and Gene Therapy is highly preferred.
• Handle issues appropriately and with a sense of urgency.
• Excellent writing skills coupled with ability to edit complex material to ensure accuracy, clarity, and effectiveness.
• Ability to work collaboratively across functions within a very fast-paced work setting and can juggle all priorities with good and positive energy.
• Ability to work well and interact, cooperate, and even motivate across departments and functions.
• Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Self-starter and must function well under minimal supervision.

If interested in learning more, please reach out to Bria Gaber at (646) 430-1191 or bria.gaber@investigo-us.com.