- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high- quality presentations for both… 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 ... development program and life cycle management, and ensure they meet current regulatory standards, are of high quality , consistent, and complete.Establish product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs Quality strategy by partnering with members and ... the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews of… more
- Post Holdings Inc. (Lakeville, MN)
- …about pet nutrition and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs ** , where you'll lead a ... Quality teams. + Support commercialization efforts by ensuring regulatory readiness from concept to shelf. + Educate internal...years of experience in pet food, food science, or regulatory affairs . + Proven leadership experience managing… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review + Lead and mentor team members +… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate...Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance) and the ability to be creative and… more
- Endo International (St. Louis, MO)
- …Building Effective Teams **RELATIONSHIP WITH OTHERS:** Reports to the Sr Director , Quality and Regulatory Affairs . Manages group of exempt direct ... work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to… more
- BeOne Medicines (San Mateo, CA)
- …detail in all aspects of content creation and review, ensuring compliance with regulatory and quality standards. + Manage all technical aspects ofMedical Review ... **General Description:** The Senior Manager, Global Medical Affairs Omnichannel Content is responsible for the development, approval, and delivery of high- quality… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …timelines, submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality ) to facilitate ... in. Are you?About the Role:We're looking for an Associate, Regulatory Affairs Operations on the Regulatory...for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for… more
- Insmed Incorporated (San Diego, CA)
- …and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as well as overall ... of science, we're in. Are you?About the Role:We're looking for an Associate Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- DHL Express, Inc. (Plantation, FL)
- …improve our services. + Trade Knowledge Support: Review, interpret (in conjunction with regulatory affairs and knowledge support, whether regional or local, or ... lives. **Grow YOUR career with DHL today ** The Director of Customs Customer Support for DHL Express Americas...Support reports to the Vice President of Customs and Regulatory Affairs for the Americas. **Key Responsibilities:**… more
- Eisai, Inc (Nutley, NJ)
- …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 ... research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …or fellowship in a related field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- BeOne Medicines (Emeryville, CA)
- …**Cross-Functional & External Engagement** + Serve as the analytical liaison across GCO, Regulatory , Medical Affairs , Access, and Corporate Affairs to ensure ... **General Description:** Reporting to the Head/ Director of Clinical Trial Diversity, the Associate ...regulatory feedback to strengthen enrollment practices and operational quality . + Build and maintain relationships with research sites… more
- Olympus Corporation of the Americas (Westborough, MA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... + Minimum of 7 years experience managing the business aspects of quality and regulatory projects. + Good analytical toolkit. + Ability to influence outside of… more
- Lundbeck (Deerfield, IL)
- …+ Implement performance metrics and dashboards to assess MSL impact and engagement quality . + Ensure compliance with regulatory and internal standards across all ... Senior Director Head, Field Medical Neuro Rare Requisition ID:...Capture, synthesize and report field insights to inform clinical, regulatory , and commercial planning. + Prepare field medical for… more
- BWX Technologies, Inc. (Oak Ridge, TN)
- …including environmental reviews, safety analysis, emergency preparedness, and NRC engagement. ** Regulatory Affairs & Licensing** + Direct all licensing ... in the United States. BWXT is seeking a seasoned Director of Licensing & Safety to lead the development...Safety to lead the development and execution of world-class regulatory compliance, safety, licensing, and quality programs… more
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