- Tris Pharma (Monmouth Junction, NJ)
- …evaluate and communicate safety observations. The incumbent functions independently as a subject - matter expert ( SME ) while working collaboratively ... planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality , etc. to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to… more
- Merck & Co. (Rahway, NJ)
- …findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide. Act as the subject matter expert and primary point of contact for ... as quality management systems and quality control tools. Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.Experience… more
- Eisai, Inc (Raleigh, NC)
- …(where applicable), industry standards and internal company policies.Applies knowledge and experience as a Subject Matter Expert ( SME ) across and beyond ... integration and achievement of needs from cross-functional stakeholders including Supply Operations, Quality (EMQO), Global Labeling, Regulatory Affairs are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert in meeting or teleconferences with Health ... limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The...industry best practice in statistical methodology. May act as Subject Matter Expert for Statistics,… more
- Stryker (Portage, MI)
- …to apply? Here are 10 reasons to join our Regulatory Affairs / Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- ... our award-winning organization by visiting stryker.com We are currently seeking a **Principal Regulatory Affairs Specialis** t for our Medical division to be… more
- Stryker (Bloomington, MN)
- …to ensure corporate goals and strategies are met. + Serve as Subject Matter Expert for regulatory processes. + Provide guidance, recommendations, and ... to apply? Here are 10 reasons to join our Regulatory Affairs / Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-… more
- ThermoFisher Scientific (Florence, SC)
- …by fostering effective interdepartmental and cross functional partnerships. 8. Serve as a technical subject matter expert ( SME ) in support of department ... with 5+ years meaningful experience. **Experience:** Prefer 2 years direct experience in regulatory affairs / Quality Assurance, analytical r&D, or quality … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and policies as it pertains to the Quality Management System (QMS). + Serve as a Subject Matter Expert ( SME ) and point of contact for all GSHC ... Global Ship Hold Center, and will work closely with the following groups: + Quality Assurance/ Regulatory Affairs (QA/RA): Ensures compliance with quality … more
- Abbott (Pleasanton, CA)
- …and listing information. Assists with compliance to product post-marketing approval requirements. + Subject Matter Expert ( SME ) for audits and ... female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Heart Failure Division… more
- Stryker (Mahwah, NJ)
- …in the policies and procedures related to biocompatibility. + Act as biocompatibility subject matter expert to align to best practices, benchmarking ... to apply? Here are 10 reasons to join our Regulatory Affairs / Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-… more
- AbbVie (Chicago, IL)
- …recognized as a resource & leads the department as a subject matter expert ( SME ) for Regulatory . + Presents pertinent regulatory information to ... or Industry-related experience. + Preferred Experience: 5 years in pharmaceutical regulatory affairs . + Demonstrates effective communication skills in written… more
- CSL Behring (King Of Prussia, PA)
- …ensure the latest thinking is applied to regulatory strategies and acts as subject matter expert . Evaluate draft guidelines and write impact assessments. ... you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located... regulatory agencies. o Serve as the primary regulatory interface to relevant global technical expert … more
- Abbott (Columbus, OH)
- …emerging regulations for business impact and make recommendations based on assessment. + Act as a subject matter expert for IT systems used by the local ... life. Our location in **Columbus, OH** currently has an opportunity for a ** Regulatory Affairs Specialist** **.** As an individual contributor, the function of… more
- Walgreens (Deerfield, IL)
- …members of the company. **Job Responsibilities** + Acts as the regulatory compliance subject matter expert for Health & Wellness product innovation with ... including disability/veterans". \#LI-RD1 **Job ID:** 1394112BR **Title:** Manager, US Regulatory Affairs & Compliance **Company Indicator:** Walgreens… more
- Olympus Corporation of the Americas (San Jose, CA)
- …the organization. + Translates business use cases into technical specifications. + Serves as a Subject matter expert ( SME ) for M365 productivity tools: ... 13485 and the ability to educate others on related subject matter . + Strong Quality ...United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs … more
- Colgate-Palmolive (Topeka, KS)
- …Compliance) + Lead regulatory packaging compliance team and serve as the subject matter expert for all aspects of packaging compliance including ... This position will also serve as the technical and regulatory expert (for packaging compliance and registration...and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... Senior Global MDR Submission is responsible for managing Market Quality - COE MDR team for the regulatory ...parties as needed. This position will also provide MDR SME support for Market Quality as required… more
- Danaher Corporation (Marlborough, MA)
- …import/export, and other biomanufacturing regulatory documentation risks. + Acts as subject matter expert and maintains current knowledge of ... yourself and us - working on challenges that truly matter with people that care for each other, our...to develop the next generation of life-changing therapeutics. The Regulatory Affairs CMC Officer for Cytiva is… more
