- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... shared success-where every voice matters and every contribution drives progress. Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager… more
- CSL Behring (Waltham, MA)
- **Position Title:** Senior Manager , Corporate & External Affairs, R&D Portfolio **Position Purpose:** The Senior Manager , Corporate and External Affairs, ... in serving as a business partner and advisor to senior leaders, assisting with the shaping and communication of...partners. + Act as a supporting partner to the regulatory policy team providing input on advocacy opportunities, and… more
- Parexel (Boston, MA)
- … drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure ... members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a ** Senior Physician in… more
- Parexel (Boston, MA)
- …and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more
- Parexel (Boston, MA)
- …trials for local sponsorship as needed with the support of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support ... and seeking an Associate/Medical Director to support the growth of our Global Immunology and Inflammation Therapeutic Franchise. As an Associate / Medical Director,… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you ... Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides… 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 regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes… more
- Oracle (Boston, MA)
- …worldwide. **The Role** We are seeking a ** Senior Principal Product Manager ** who deeply understands the ** regulatory , clinical, and financial dynamics** of ... workflows in alignment with US federal/state and international regulations. + **Shape global regulatory content development** : Translate regulatory and… more
- Chiesi (Boston, MA)
- …Responsibilities + Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for ... others as needed. + Ensures appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory ... guidance documents that impact US activities related to Regulatory activities. + Interact with senior management,… more
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