Responsibilities :
- Author and review high-quality, compliant CMC regulatory documents (, Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings) and support client in responding to health authority questions within defined timelines.
- Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
- Assesses currently registered content, proposed changes, and justification for changes by utilizing client's change control system during pre-submission planning.
- Responsible for regulatory operational activities including organizing, tracking, and sending submissions to publishing team for US and other international markets.
- Compiles documentation for regulatory submission packages including license renewals, updates and market registration for review and submission to regulatory agencies.
- Ensures compliance with FDA, EMA, and global regulatory requirements; assures the quality of the investigational and commercial drug substances and drug products.
- Perform technical review of certificate of analysis, analytical test methods, specification, product development reports, Master Batch Records (MBR), validation protocol / report, and stability protocol / report / data.
- Work within multiple regulatory systems and tools during end-to-end submission process.
- Maintains knowledge of current FDA, EU, global regulations, and guidance applicable to marketed products.
- Support and prepare other CMC ad-hoc requests as per client requests.
Requirements :
- A bachelor's degree in a health or life science discipline is required; Advanced degree is preferred.
- years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
- Ability to read, analyze and interpret technical documents and health authority regulations.
- Demonstrated experience authoring CMC sections in Module , and sections of regulatory filings required.
- Familiar with Common Technical Document (CTD) formatting.
- Working knowledge of the US and European regulations and ICH guidance is preferred.
- Demonstrated experience using regulatory systems and tools (, Track Wise and Veeva Vault are preferred.
- Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).
Global Senior Specialist, Publishing - Regulatory Affairs
The Regulatory Operations Senior Publishing Specialist is responsible for the planning, creation, and submission of regulatory submissions. The Senior Publishing Specialist provides regulatory operations expertise to cross-functional submission project teams, promoting and bringing excellence in pla...
Principal Ultrasound Regulatory Affairs Specialist
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post-market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Sr. Regulatory Affairs (RA) Specialist
Regulatory Affairs (RA) Specialist?. Regulatory Affairs (RA) Specialist who wants to grow your skills and take the lead on U. Plan and perform regulatory submissions, product registrations/listings and renewals towards FDA, Health Canada and other Regulatory Authorities. Coordinate and prepare respo...
Senior Regulatory Affairs Specialist-Animal Tissue
Title: Senior Regulatory Affairs Specialist-Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary. Able to t...
Sr Specialist, Regulatory Affairs
The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. Support and eventually manage interactions with regula...
Regulatory Affairs Specialist
Author and review high-quality, compliant CMC regulatory documents (, Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings) and support client in responding to health authority questions within defined timelines. Compiles documentation for regulatory submission...
Senior Regulatory Affairs Specialist-Animal Tissue
Senior Regulatory Affairs Specialist-Animal Tissue. Will report to the VP of Regulatory Affairs . Candidate will be responsible for regulatory activities related to Animal Tissue . Respond to regulatory authorities of any questions related to animal tissue. ...
Regulatory Affairs Specialist
The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to + investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an op...
Principal Ultrasound Regulatory Affairs Specialist
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
Regulatory Affairs Specialist—Biotechnology Crop Traits
Yield10 is searching for a Regulatory Affairs Specialist. The successful candidate will support regulatory activities at Yield10 Bioscience including drafting, securing, and submission of USDA-APHIS BRS permits and notifications for movement and release of regulated crop material, overseeing regulat...