- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... address diversified, unmet medical needs of people globally by leveraging our world- class science and technology. With more than 100 years of scientific expertise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …address diversified, unmet medical needs of people globally by leveraging our world- class science and technology. With more than 125 years of scientific expertise ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , ... we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director ...on the content of labels in the same therapeutic class , competitor labeling and labeling trends, proposing content as… more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety and efficacy part… more
- Caldera Medical (Westlake Village, CA)
- Director of Regulatory Affairs ...expansion. Duties and Responsibilities: * Define and execute global regulatory strategies for Class I, II and ... Life for Women! Message from the Hiring Manager: The Director of Regulatory Affairs will...Proven track record with global submissions and approvals for Class I, II and III devices. * In-depth knowledge… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you will contribute:**… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities...military status, application for military service, or any other class protected by state or federal law. Headquartered in… more
- Unilever (El Segundo, CA)
- …as an infinite supply of Liquid IV for extraordinary hydration. **About the Role:** The Director of Regulatory Affairs leads the Regulatory Affairs ... company. + Team Development & Leadership: Lead, mentor, and cultivate a high-performing Regulatory Affairs team with a strong emphasis on leadership development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative global ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... Description** **About the role:** At Takeda, we are a forward-looking, world- class R&D organization that unlocks innovation and delivers transformative therapies to… more
- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and ... sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with...+ Strong understanding and experience with US and global regulatory requirements for class II medical devices… more
- Chiesi (Cary, NC)
- …+ Promotional Material/External Communications Responsibilities: + Heads Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... + Prepare Standard Operating Procedures for related activities and provide training to Regulatory Affairs and other departments as appropriate. + Review and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Description** **About the role:** At Takeda, we are a forward-looking, world- class R&D organization that unlocks innovation and delivers transformative therapies to ... as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA… more
- Boehringer Ingelheim (Ridgefield, CT)
- …that our strength and competitive advantage lie with our people. The Senior Associate Director , Medical Affairs Strategy Team Member serves as the subject matter ... customer channels including Health Systems and Payers. The Senior Associate Director , Medical Affairs Strategy Team Member collaborates cross functionally… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology. ... development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead, Hematology** proactively defines and drives… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs...information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable… more
- RWJBarnabas Health (New Brunswick, NJ)
- …Location: One Robert Wood Johnson Place, New Brunswick, NJ 08901 Job Title: Director Location: RWJ New Brunswick Department: Medical Affairs Req#: 0000190120 ... the candidate's educational background, skills and professional experience. Job Overview: The Director of Medical Affairs organizes and directs Medical Staff… more
- State of Minnesota (St. Paul, MN)
- **Working Title: Media & Public Affairs Director ** **Job Class : Communications Manager 1** **Agency: Commerce Department** + **Job ID** : 87739 + ... listed on the job posting with questions** The Media & Public Affairs Director leads proactive communications strategy for the Minnesota Department… more
