- Medtronic (North Haven, CT)
- …for this opening will close on - 30 Dec 2025 **Position Description:** Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located ... support product registration and market access in US and international markets including Egypt, LATAM, Europe, and Asia, ensuring...field and four (4) years of experience as a Regulatory Affairs Specialist or related… more
- Medtronic (North Haven, CT)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for working collaboratively ... review processes. + Share business and product information with international regulatory teams to inform strategy and...Minimum Requirements** + Bachelors degree with 4+ years of regulatory affairs experience in the medical device,… more
- Sumitomo Pharma (Hartford, CT)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies...transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Legal, Epidemiology & RWE, early and late-stage Clinical Development teams, Regulatory Affairs , Drug Safety, Digital). **Eligibility Requirements** : + ... from launch through lifecycle. + Acts as Team Member Medical Affairs (TMMA) and collaborates cross-functionally (Clinical Development, Regulatory , Safety,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …global functions (eg Epidemiology, early and late-stage Clinical Development teams, Regulatory Affairs , Drug Safety, Marketing, PPSS (Product Pipeline Scientific ... + Provides product specific input to global Pharmacovigilance (PV) and global Regulatory Affairs (RA). + Develops and/or provides input to, and… more
- Lilly (Stamford, CT)
- …This position requires close collaboration with cross-functional partners including medical affairs , clinical operations, regulatory , statistics and data science ... related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes… more
- Deloitte (Hartford, CT)
- …professionals. Qualifications Required: + Bachelor's degree is required, preferably in International Relations/ Affairs , Public Affairs or Public Policy, ... Our Deloitte Regulatory , Risk & Forensic team helps client leaders...value creation. Work You'll Do As a Project Delivery Specialist on the project, you will lead and contribute… more
- Boehringer Ingelheim (Ridgefield, CT)
- …training and facilitation skills. + Strong track record of interactions with regulatory affairs authority, international societies and other relevant ... of key deliverables within his/her area of responsibility. + Support annual international medical budgeting process as delegated by the TA HoEM. + Supports… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of drug development and how the US Code of Federal Regulations and International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) set the framework ... of required trial documents, contracts and necessary approvals + All Regulatory Requirements are satisfied prior to trial/site initiation + Where necessary,… more