- Parexel (Boston, MA)
- We are seeking a motivated ** Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major ... Qualifications * Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs , or related field. Experience: * 3-5 years of pharmaceutical/biotech… more
- Parexel (Boston, MA)
- …professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure our client's ... developing contingency plans for CMC-related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ... regulatory or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of dossiers for registration on for… more
- Dentsply Sirona (Waltham, MA)
- …channels, enhancing business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to ... Education: + Bachelor's degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. + Regulatory Certification (such as… more
- Olympus Corporation of the Americas (Westborough, MA)
- …healthcare beyond traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies ... Olympus' digital transformation journey. This position supports the Global Senior Manager to plan and direct the OSTA Core... Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality,… more
- Baystate Health (Springfield, MA)
- …- Maximum $162,800 - $226,100 **Position Summary:** The **Vice President of Safety and Regulatory Affairs ** is a senior executive responsible for leading the ... of delivering safe, high-quality, and patient-centered care. The VP of Safety and Regulatory Affairs also directs development and implementation of a system wide… more
- GRAIL (Boston, MA)
- …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
- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... departments to ensure product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate. + Review and… more