- Syner-G BioPharma Group (Boston, MA)
- …cGxP Quality Systems within an FDA -regulated manufacturing company.Knowledge of FDA regulations and guidance or applicable regulatory standards and ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to...cGMP Manufacturing within an FDA -regulated manufacturing company.Knowledge of… more
- Sanofi (Cambridge, MA)
- …part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- Sanofi (Cambridge, MA)
- Job Title: Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the ... be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional… more
- Cipla (Fall River, MA)
- …is responsible for managing controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. ... This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, including creation, review, approval, distribution, and archival. JOB DESCRIPTION The QA Document Control Associate… more
- Cipla (Fall River, MA)
- …Verifying process validation and characterization-related documents. Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange ... Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements, FDA & ICH guidance requirements, etc. Technical Knowledge and Computer… more
- Cipla (Fall River, MA)
- …schedules of projects. Monitor packaging processes for adherence to cGMP, FDA , and Cipla's quality standards. Identify and resolve operational inefficiencies, ... experience in pharmaceutical MDI packaging.Skills/ Competencies Understanding of cGMP, FDA regulations, and pharmaceutical packaging processes. Experience in SAP… more
- Cipla (Fall River, MA)
- …ensures compliance with cGMP's, InvaGen Pharmaceutical's policies,standard operating procedures, and FDA requirements. The incumbent will serve as a key resource ... complaints, supporting packaging, and packaging components within approved proceduresand regulatory requirements. The job duties for this position include but… more
- Lundbeck (Boston, MA)
- …Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies ... and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or… more
- Cipla (Fall River, MA)
- …cGMP policies, documentation and record keeping in accordance with industry and FDA standards and Safety and sanitation regulations. Performs a combination of manual ... instructions and document results. Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred. Basic… more
- GRAIL (Boston, MA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
