- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** - Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for the ... with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- Merck (Boston, MA)
- …with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our company ... **Job Description** The Director /Principal Scientist, Regulatory Affairs Liaison, is...all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...are established and maintained. + Provides input into the global organization for labeling strategies of marketed… more
- Chewy (Boston, MA)
- …and competitive regulatory intelligence, while ensuring compliance with global regulatory frameworks, including EU feed/food regulations, Canadian CFIA ... compliance, quality assurance, and ethical sourcing. The **Associate Director , Global Compliance & Ethical Sourcing** will...FDA, AAFCO, NASC, FSMA, FSVP, USDA, Prop 65, and global regulatory frameworks. + Strong background in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Therapeutic area knowledge + Expertise in acute stroke or stroke recovery + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... Medical Director leads and drives strategy for the overall global (US/EU/Japan/China) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …abilities **Knowledge** + GI and/or Inflammation therapeutic area knowledge desired + Regional/ global Regulatory requirements + GCP/ICH This position is ... and empower you to shine? Join us as a Director , Clinical Science in our GI2 Therapeutic Area Unit...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …matrix teams + Diplomacy and positive influencing abilities Knowledge + Regional/ global Regulatory requirements + GCP/ICH This position is ... Medical Director leads and drives strategy for the overall global clinical development of assigned Takeda pipeline compound(s) taking into consideration the… more
- Takeda Pharmaceuticals (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Organon & Co. (Boston, MA)
- …2.7.2 and contribute to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, ... in the US + There are **2 openings** The Director , Clinical Pharmacology Lead will be responsible for contributing...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the Global Medical Safety ... Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …and simulation activities as appropriate for the project. + Contribute to regulatory documents including Investigator Brochures, Labeling and those required for ... is true to the best of my knowledge. **Job Description** ** Director , Clinical Pharmacology** **Cambridge, MA** **Hybrid** **Job Posting Description** The PDT… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Rhythm Pharmaceuticals (Boston, MA)
- …as required. + Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc). Qualifications and Skills + ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the...to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Medical Director Pharmacovigilance, Rare Disease & PDT **POSITION DESCRIPTION** : Takeda ... Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following...Disease & PDT with the following duties: Serve as Global Safety Lead (GSL) and the Company-wide patient safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Takeda Pharmaceuticals (Boston, MA)
- …needs including sourcing strategy, inventory management, kit assembly, packaging & labeling and distribution of ancillary supplies to clinical sites Provides ... relationships and drives effective collaboration with Clinical Operations, PharmSci, PSDQ, Regulatory , and other stakeholders to ensure process is effective and… more