- Merck & Co. (San Diego, CA)
- …in Immunology.Experience with biologics or small moleculesSubstantial experience in US & International Regulatory Affairs with prior experience as a Global ... License:NoHazardous Material(s):n/aRequired Skills:Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance, Leadership, Motivation Management, Pharmaceutical… more
- Merck & Co. (North Wales, PA)
- …technical issues.Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.Strong analytical and decision-making abilities, combined ... Engineering, Packaging Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management, Root Cause Analysis (RCA), Technical… more
- Insmed Incorporated (San Diego, CA)
- …teams)Ability and experience in the development and execution of Global regulatory strategyIn-depth knowledge and direct application of US/EU/Japan/ International ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Merck & Co. (Rahway, NJ)
- …as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable ... Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement ... assessments).This individual will ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy ... all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have advanced experience working on Phase ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… more
- Merck & Co. (Rahway, NJ)
- … regulatory reporting, publication, and presentation at national and international meeting.- They will provide internal scientific leadership for cross-functional ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Lundbeck (Bothell, WA)
- …supporting regulatory submissions including authoring, reviewing, and responding to regulatory questions. TRAVEL Domestic and international travel up to 20% ... capacity, manage outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize… more
- Merck & Co. (Rahway, NJ)
- …substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support enterprise ... commercialization teams across the end to end supply chain, and analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership and… more
- Tris Pharma (Monmouth Junction, NJ)
- …anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
- Tris Pharma (Monmouth Junction, NJ)
- …pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the US We also license ... in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant regulations Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.A key focus will be ... closely with our QA organization to implement ongoing learnings from regulatory inspections.Engage and motivate Clinical Operations employees to execute the strategy… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- Merck & Co. (Rahway, NJ)
- …external stakeholders such as drug substance, drug product, device, analytical, regulatory , project leaders, manufacturing sites, and other key stakeholders in CMC ... and coaching to team members Remain informed of current quality and regulatory requirements and industry trends as described in worldwide regulations and industry… more
- Tris Pharma (Monmouth Junction, NJ)
- …anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also ... and accurately documents all activities to ensure compliance with regulatory guidelines.ESSENTIAL FUNCTIONS Primary duties/responsibilitiesSupports and assists in the… more
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