- AbbVie (Worcester, MA)
- … regulatory guidelines. + Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies ... the qualification and validation of analytical methods in accordance with ICH, FDA , and USP guidelines, ensuring methods are suitable for late-phase development and… more
- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Sumitomo Pharma (Cambridge, MA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Norstella (Boston, MA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Sanofi Group (Cambridge, MA)
- …a highly visible and priority launch asset for Sanofi Specialty Care. Since its FDA approval in 2023, ALTUVIIIO has been steadily gaining market share and represents ... lead initiatives: Patient Services, Market Access, Sales force, Medical, Legal, Regulatory , Business Ops and Multiple agencies + Detail-oriented self-starter capable… more
- Wolters Kluwer (Waltham, MA)
- …well understood, technically feasible, and delivered on time and with quality . * Collaborate with go-to-market teams (Marketing, Sales, Pricing, Customer Experience) ... Demonstrated success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder… more
- Bristol Myers Squibb (Devens, MA)
- …resources at all levels. + Demonstrated hands on supplier management implementation in regulatory agencies like: FDA , ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA ... stakeholders. + Lead global investigations in collaboration with Global Quality Supplier Leads, BMS Site Supplier Quality ,...Global Quality Supplier Leads, BMS Site Supplier Quality , and SQE teams. + Perform trending analysis of… more
- Teleflex (Chelmsford, MA)
- …medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in ... totally Customer Centric in our unrelenting focus on Improving Quality , Service and Value as perceived by our customers....at all times. Assures compliance with GMP (ISO 13485, FDA 21 CFR 820, MDD 93/42EEC, and all applicable… more
- Takeda Pharmaceuticals (Lexington, MA)
- …systems like COMOS and Veeva. + Ensure compliance during audits, author regulatory filings, and support safety inspections through comprehensive data preparation. + ... experience and accomplishments. + Proficiency in cGMP Engineering within FDA -regulated industries (pharmaceutical or biotechnology) and strong understanding of Good… more
- Medtronic (Boston, MA)
- …to commitments. + Anticipate and mitigate risks, balancing time, schedule, cost, and quality , while adhering to safety and regulatory standards. + Manage project ... lead a dynamic team, collaborating across departments like R&D, Quality Affairs, and Marketing to spearhead a series of...Resource First + Experience working under regulations of the FDA , notified bodies, and other regulatory agencies… more