- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device Development & ... Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... date: -As soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation &… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... and validation according to regulatory guidelines such as ICH, FDA , and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy,… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director HVAC : The HVAC Associate Director is responsible for leading and developing a team that supports HVAC operations and ... within a highly regulated environment, combined with leadership skills to manage teams effectively.The Associate Director of HVAC is a key role within the Global… more
- Eisai, Inc (Phoenix, AZ)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with office management to provide various informational… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Associate Director , Validation & Engineering** Catalent Pharma Solutions is looking to hire a ** Associate Director , Validation & Engineering** to lead ... and will house 8 CGMP manufacturing suites and cold storage warehousing. The ** Associate Director , Validation & Engineering** is responsible for the strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the ... meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director or ... strategies for projects in their assigned therapeutic area portfolio. **Responsibilities** The Associate Director will be responsible to: + Develop regulatory… more
- Boehringer Ingelheim (St. Joseph, MO)
- …through activities such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs ... of regulatory tools as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety and efficacy part of… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... Global Regulatory Affairs and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly complex or multiple… more
- Takeda Pharmaceuticals (Boston, MA)
- …monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage with CPMQ ... continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the CPMQ team… more
- BeOne Medicines (Pennington, NJ)
- **_General Description:_** Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site. Programs which require ... the job_** **_:_** + Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ Site. Ensuring the strategy meets the… more
- Abbott (Alameda, CA)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Associate Director , Medical Events Group** **Working at Abbott** At Abbott, ... glucose levels with our new sensing technology. As the Associate Director , Medical Events Group, you will...is responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in the… 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 A&P) ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...of action and drug landscape as well as maintaining compliance in accordance with FDA , EMEA, ICH… more
