Associate Director, Regulatory Affairs-CMC
BlueRock Therapeutics, Cambridge, MA, United States
Overview
Associate Director, Regulatory Affairs - CMC (BlueRock Therapeutics, LP; Cambridge, MA): The Associate Director, Regulatory Affairs - CMC provides regulatory leadership and guidance to CMC teams developing cell and gene therapy products. This includes oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories. The role works closely with technical CMC teams in the USA and Canada, project teams, and serves as the point of contact for interactions with global health authorities to align regulatory strategies for the BlueRock portfolio.
Responsibilities
Represent regulatory CMC on and/or lead matrix teams for the cell and gene therapy pipeline products.
Independently provide strategic guidance/input related to current regulatory requirements and expectations for CMC-related clinical trial and marketing applications.
Independently manage and prioritize multiple complex projects.
Drive workflows related to Health Agency interactions (e.g., briefing documents and responses to questions).
Interface with Health Authorities for CMC submissions and CMC-related issues, with guidance from the departmental head on complex topics (e.g., comparability, specification changes).
Identify, communicate, and propose resolutions to routine and complex strategic issues; interpret global regulations and guidance.
Identify regulatory opportunities and risks; anticipate and communicate possible regulatory paradigm shifts.
Review and provide regulatory assessments on change controls.
Prepare and manage CMC submissions for global markets, ensuring thoroughness, completeness, and timeliness; create and maintain strategy documents.
Manage relationships with diverse teams in a collaborative manner.
Utilize electronic systems for dossier creation and tracking.
Support departmental initiatives, including special projects, budgeting, and authoring departmental documents.
Telecommuting permitted. 25% travel within US/Canada (some additional, limited EU travel possible).
Minimum requirements
Bachelor's degree or equivalent in Regulatory Science or related field plus 6 years of experience in Regulatory Affairs, CMC.
Must have
Experience in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products.
Direct experience interfacing with regulatory authorities.
Extensive experience in preparing quality sections of regulatory filings including health authority briefing documents, IND/CTA and NDA/BLA/MAA; ability to lead regulatory CMC discussions with global regulatory authorities.
Experience preparing electronic submissions following eCTD format.
Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
Experience in leading the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.
Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.
Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations.
Excellent written and communication skills with attention to detail.
Highly computer literate (Word, Excel, PowerPoint), including formatting documents for regulatory submission.
Note on employment An equal employment opportunity (EEO) statement is applicable to this posting.
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Responsibilities
Represent regulatory CMC on and/or lead matrix teams for the cell and gene therapy pipeline products.
Independently provide strategic guidance/input related to current regulatory requirements and expectations for CMC-related clinical trial and marketing applications.
Independently manage and prioritize multiple complex projects.
Drive workflows related to Health Agency interactions (e.g., briefing documents and responses to questions).
Interface with Health Authorities for CMC submissions and CMC-related issues, with guidance from the departmental head on complex topics (e.g., comparability, specification changes).
Identify, communicate, and propose resolutions to routine and complex strategic issues; interpret global regulations and guidance.
Identify regulatory opportunities and risks; anticipate and communicate possible regulatory paradigm shifts.
Review and provide regulatory assessments on change controls.
Prepare and manage CMC submissions for global markets, ensuring thoroughness, completeness, and timeliness; create and maintain strategy documents.
Manage relationships with diverse teams in a collaborative manner.
Utilize electronic systems for dossier creation and tracking.
Support departmental initiatives, including special projects, budgeting, and authoring departmental documents.
Telecommuting permitted. 25% travel within US/Canada (some additional, limited EU travel possible).
Minimum requirements
Bachelor's degree or equivalent in Regulatory Science or related field plus 6 years of experience in Regulatory Affairs, CMC.
Must have
Experience in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products.
Direct experience interfacing with regulatory authorities.
Extensive experience in preparing quality sections of regulatory filings including health authority briefing documents, IND/CTA and NDA/BLA/MAA; ability to lead regulatory CMC discussions with global regulatory authorities.
Experience preparing electronic submissions following eCTD format.
Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
Experience in leading the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.
Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.
Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations.
Excellent written and communication skills with attention to detail.
Highly computer literate (Word, Excel, PowerPoint), including formatting documents for regulatory submission.
Note on employment An equal employment opportunity (EEO) statement is applicable to this posting.
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