- Parexel (Hartford, CT)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… more
- GRAIL (Hartford, CT)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Sumitomo Pharma (Hartford, CT)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Otsuka America Pharmaceutical Inc. (Hartford, CT)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- United Therapeutics (CT)
- …communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Otsuka America Pharmaceutical Inc. (Hartford, CT)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Boehringer Ingelheim (Ridgefield, CT)
- …field with eight to ten (8-10) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required OR Master's degree with a ... or related field with six (6) years' experience in the pharmaceutical industry in Regulatory Affairs or scientific discipline required. + Minimum five (5) years… more
- Otsuka America Pharmaceutical Inc. (Hartford, CT)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Senior Clinical Program Leader assumes global Clinical Development responsibilities supporting early or late development projects, reporting to ... the Associate Global Head or the Global Clinical Programme Team Leader. The Senior Clinical Program Leader has a medical leadership role for a project or a… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational ... medicine subspecialty would be an asset. + People leadership potential required. Senior Associate Director: + Total applicable experience (incl. clinical… more