- WuXi AppTec (DE)
- **Overview** This position is responsible for leading the business development activities within STA, WuXi's CMC small molecule development and manufacturing ... This position manages sites for key accounts and is also responsible for business development for any new accounts. This position works proactively with other BU… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for the development ... (IFU) documents and Device Container Labeling content in line with US and EU standards and guidelines. Provide strategic and tactical labeling expertise to teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of...or creation of a new TLP, CCDS, USPI and EU SmPC. **How you will contribute:** **Management of Labeling… more
- J&J Family of Companies (Raritan, NJ)
- …Management** : Using strong methodologies, create pertaining project plans, including budget development (CAR creations). Lead in developing business case(s) for ... member of Johnson & Johnson Family of Companies, is recruiting for a Director , Strategic Capabilities - Packaging Environmental Compliance in Raritan, NJ Please note… more
- Takeda Pharmaceuticals (Boston, MA)
- …Leads the Global Development Team (US, EU , Japan) managing both the US/ EU Development Team and the Japan Development team for assigned compounds. In ... some cases may lead the US/ EU Development Team but more likely will...the successful completion of related objectives. + **Due Diligence, Business Development and Alliance Projects** + Responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …Emerging Markets (GEM; eg, China), Project Leadership, Finance, Corporate Communications and Business Development + Develop and manage strong collaborations with ... Drive value demonstration strategies for Health Technology Appraisal (HTA; including the EU Joint Clinical Assessment [JCA]) and payer assessments to optimize rapid,… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Oncology Business Development and Global Regulatory ... global strategies in line with applicable regulations to achieve business objectives for development and marketed products....as EU or Japan. Strong global drug development foundation with business acumen. + Note:… more
- Arvato Bertelsmann (Demotte, IN)
- Arvato is hiring a self-motivated and entrepreneurial-minded Director of Business Development to join our growing team! In this role, you will be able to ... warehousing, retail distribution and end-to-end supply chain solutions. * Work with Business Development , Marketing, Solution Design and Logistics Engineering on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we ... matters, and everyone has a chance to enhance their skills through ongoing development . Our scientific focus has resulted in marketed products that are benefiting… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and strategic quality guidance/advice to the MA functions located in the Americas and EU and collaborate with Research QA and Development QA to provide QA ... rare diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV...aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit… more
- Abbott (Santa Clara, CA)
- …Oversee development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files + Manage relevant standards and ... Our 114,000 colleagues serve people in more than 160 countries. ** Director , Biocompatibility** **Position Summary** Responsible for Biocompatibility support to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Global Development Team (US, EU , and others) managing both the US/ EU Development Team and the Japan/ China Development team for assigned ... compounds. In some cases may lead the US/ EU Development Team but more likely will...nominations and reviewers of external compounds as part of business development efforts + Liaison with Clinical… more
- Wolters Kluwer (Chicago, IL)
- …the business teams in Legal, Regulatory, Clinical, Marketing, and Product Development and within the broader Wolters Kluwer business to ensure consistent ... with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA, and EU MDR. + Perform design control activities focused on 21 CFR 820, ISO 13485, and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to own the financial evaluation model developed in close collaboration with Global Business Development (US, Japan, EU teams), Finance (Corporate FP&A ... the materials, and develop comprehensive opportunity assessments consistent with our corporate business development strategy. This position may lead a small team… more
- BioBridge Global (San Antonio, TX)
- … business processes to support the department's objectives. The Director will collaborate with customers and stakeholders to establish requirements and ... locations in San Antonio and Atlanta_ General Summary The Director of QualTex Lab Services will lead and oversee...regulations, including FDA, CLIA, GMP, CAP, AABB, ISO, and EU standards. Oversee quality control procedures, maintain records, and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …leadership for the successful completion of related objectives. + **Due Diligence, Business Development and Alliance Projects** + Responsible for identification ... leads and drives strategy for the overall global (US/ EU /Japan/China) clinical development taking into consideration the...and evaluation of potential business development opportunities, conduct due diligence evaluations,… 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 Medical ... global regulatory standards and manage implementation of those changes into company business processes. + Work proactively cross-functionally to ensure new product … more
- Bristol Myers Squibb (Princeton, NJ)
- …models in US, and EU , Japan, Asia and LatAm, to guide development strategies. + Represent medical perspective in business development . + ... or Development preferred + Previous commercial experience is preferred + Business development experience preferred The starting compensation for this job is… more
- Lilly (Indianapolis, IN)
- …continuous and disparate regulatory changes worldwide including: + Responsible for the development of new business processes and maintenance of existing system ... make life better for people around the world. **Sr. Director / Executive Director - Safety Data...leadership and share best practices in system and associated business process execution and development with cross… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition ID: 6420 Location: Deerfield, IL, US Do you want to join a team where the mission ... - open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee the … more