- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be ... Affairs Impact and Omnichannel strategy. This is a global role which will work across regions, functions and...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on… more
- Insmed Incorporated (San Diego, CA)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... teamsWith oversight from the VP of Regulatory Affairs , lead the development and implementation of global... Affairs , lead the development and implementation of global regulatory strategy plans to facilitate efficient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our ... regulatory submissions, maintaining licences and liaising with government authorities.The Regulatory Affairs Manager plays a critical part in ensuring… more
- Insmed Incorporated (NJ)
- …regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory ... agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development… more
- Merck & Co. (Rahway, NJ)
- …Leadership Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... MAA) and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we work together to change lives for the better. The Position The Director , Media Relations & Issues Management is accountable for establishing and leading Novo ... to dramatically influence stakeholder perceptions. Relationships Reports to the Senior Director , Media & Stakeholder Relations, and interacts with senior leaders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... for the future of science, we're in. Are you?About the Role:The National Senior Director , US Field Medical is responsible for the direct leadership of the Chronic… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Insmed Incorporated (San Diego, CA)
- …closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.What You'll Do: EDC System ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The Associate Director , EDC Programming will lead and oversee EDC programming,… more
- Eisai, Inc (Nutley, NJ)
- …to the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets and global value and access teams. ... difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion ... prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Candela Corporation (Marlborough, MA)
- ** Director , Global Regulatory Affairs ** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company ... distributors in over 60 other countries. **General Summary** The Director , Global RA will be fully accountable...+ Global accountability to establish/maintain a high-performance Regulatory Affairs team. + Actively support New… more
