- 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... progress. The Associate Director , Global Regulatory Affairs - Global Labeling ... function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements (FDA,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global...possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Technologies (RIM systems, publishing tools, global submission management, labeling platforms, IDMP readiness). Pharmacovigilance ... Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...as the Regulatory reviewer for assigned products. This position is responsible… 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
- BeOne Medicines (Cambridge, MA)
- …expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assess impact of changes on business and ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA,...+ Facilitate policy and development of standard interpretation of global regulation. + Trains, develops, and manages an effective… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs, the Executive Director , CNS Strategy, Global Medical Affairs is a leadership ... for the strategic and tactical medical plans of both global and US medical CNS products. This individual is...Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable… more
- Takeda Pharmaceuticals (Boston, MA)
- …or a related specialty, disease mechanisms and plasma derived/related therapies + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in plasma ... empower you to shine? Join us as a Medical Director , Clinical Sciences - Plasma Derived Therapies in our...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 of regional/ global Regulatory requirements and GCP/ICH TRAVEL REQUIREMENTS: + Ability to ... inspire you and empower you to shine? Join us as a Medical Director , Clinical Science, Neuroscience TAU- Respiratory/Sleep Disorder in our Cambridge, MA office. At… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to mechanism of action . Preferably with expertise Neurology or Psychiatry . 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge + Pulmonologist/Neurologist with sleep medicine expertise + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in ... 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)
- …and positive influencing abilities Knowledge + Gastroenterology area knowledge desired + Regional/ global Regulatory requirements + GCP/ICH **TRAVEL ... you to shine? Join us as an Executive Medical Director in our GI & Inflammation Therapeutic Area Unit...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Wolters Kluwer (Waltham, MA)
- …in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device ... regulatory risks; communicate risks and lead implementation of regulatory measures. + Evaluate global regulatory...Review design inputs and proposed design changes to ensure regulatory requirements are met. + Review product labeling… 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)
- …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