- Takeda Pharmaceuticals (Lexington, MA)
- …all promotional communications for Takeda's marketed pharmaceutical products meet FDA regulations and industry standards. The department provides strategic ... promotional materials, the Ad/Promo team conducts regulatory research, tracks FDA enforcement trends, and drives process improvements. The Ad/Promo Regulatory… more
- Evident Scientific (Needham, MA)
- …Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as both a hands-on ... Act as US regulatory lead for clinical and medical device products, overseeing FDA submissions (510(k), PMA) and communications. + Ensure ongoing compliance with 21… more
- Sumitomo Pharma (Boston, MA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
- Dentsply Sirona (Waltham, MA)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… more
- Parexel (Boston, MA)
- …development. * Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. * Collaborate with global teams to ... ensure consistency across markets while meeting US-specific requirements. * Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. * Support… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate ... regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and organizes Regulatory… more
- Hologic (Marlborough, MA)
- …representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a ... Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards,… more
- State of Massachusetts (Canton, MA)
- …compliance surveys of mammography facilities in accordance with the FDA 's Mammography Quality Standards Act (MQSA). Additional responsibilities include performing ... of radiation accidents or incidents, in accordance with the State and FDA Mammography Quality Standards Act (MQSA). * Performs compliance inspections and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical,...be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other… more
- Takeda Pharmaceuticals (Boston, MA)
- …as global and/or regional regulatory lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for all US FDA submissions ... of contact with health authorities and lead and manage FDA meetings. + Define strategies, provide tactical guidance to...of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more