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Replimune Group
This position is responsible for the preparation of Module 3 and assures all relevant CMC requirements are met for regulatory submissions (including IND, BLA, CTA, etc.) to the FDA and other Regulatory Agencies.
Key responsibilities:
Prepares and coordinates the preparation of documentation packages for regulatory CMC submissions (including IND, BLA, CTA, etc.) to the FDA, and other Regulatory Agencies.
Reviews, coordinates and approves CMC regulatory documentation for inclusion in INDs, NDAs, BLAs and worldwide submissions and compile all documentation and submit to FDA and foreign regulatory agencies.
Develops and maintains current regulatory knowledge and keeps up with/implements the changes required for regulatory compliance
Maintains regulatory documentation including submissions to and correspondence with each governing authority
Coordinates collection of information from other departments (CMC, Quality Assurance, Clinical Manufacturing Operations, and Operations, etc.) for incorporation into regulatory submissions including any expedited reporting.
Reviews CMC and technical documentation for regulatory compliance
Performs other appropriate administrative duties, such as preparing correspondence and filing, where necessary
Manages resources for submission preparation and communication with internal/external customers to achieve all phases of product approval and commercialization of products.
Participate in project teams to manage activities and/or changes related to product development, manufacturing, and commercialization. Provide review of and input to development plans. When appropriate, provide guidance for problems being discussed and recommend solutions.
Assists in the evaluation of deviation, change control and product incident documents for impact on submissions and filing requirements.
Assists in reviews all promotional labeling and advertising for clinical trial and commercial labeling.
Manages external regulatory consultants and project deadlines for ex-US countries.
Additional responsibilities
Maintain current knowledge of FDA and international regulations and guidance related to clinical trials.
Knowledge of EU and rest of world (ROW) clinical trial application requirements.
Participate in the preparation of regulatory strategies/plans worldwide.
Responsible for maintenance of regulatory affairs product files to support compliance.
Review SOPs and protocols with regard to regulatory matters.
Provide mentoring to current staff and have skill sets for directly managing staff, if needed.
Educational requirements: B.A or B.S. degree in an appropriate scientific field with 10-15 years’ experience in Pharmaceutical/Biotech Industry with 8-10 years in a Regulatory CMC capacity.
Experience and skill requirements:
Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD, and CBER and/or CDER requirements for the drug approval process
Previous participation in preparing regulatory submissions (IND, BLA, CTA, etc.) to the FDA and EU Regulatory Authorities
Solid understanding of the e-CTD specifications for electronic submissions
Strong abilities in technical writing and documentation preparation/publishing using Adobe Acrobat
MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio
Strong interpersonal, organizational, and time management skills
Ability to handle matters of strict confidentiality and sensitivity
Appropriate GXP training
Excellent verbal and written communication skills
Location Requirements
Replimune is an equal opportunity employer.
Replimune now requires COVID vaccination disclosure for all US employees.
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