- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities ... supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research,… more
- Merck & Co. (Rahway, NJ)
- …operations.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... are seeking a Growth and Improvement minded Clinical Operations Manager - Regulatory that can help drive...address and resolve issues with minimal support from the Senior COM or manager .EducationRequired - bachelor's degree.Experience… more
- Aequor (Thousand Oaks, CA)
- …around technology development. Enterprise level engagement. Job Title: Senior Project Manager - End to End Regulatory Content Automation Initiative, Global ... of 5-8 YOE in project management within R&D and regulatory affairs , within pharmaceutical. Not a tech...Strategy, Position Summary: We are seeking a seasoned Project Manager with a proven track record in the pharmaceutical… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to...relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key stakeholder interactions include: Research and Early Development / Development / Global Regulatory Affairs / Global Safety / Local affiliates / Suppliers ... audits considered to be complex or difficult (either as Senior Lead Auditor or in support of peers) Act...up-to-date knowledge of legislation, guidance and general interpretation from regulatory sources, as well as relevant changes in industry… more
- Lundbeck (WA)
- …opportunity - Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager , State Policy and Strategy position is responsible for ... related to the state policy environment and collaborating with Government Affairs and cross-functional partners to ensure patient access to therapies, optimize… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs , Regulatory , Privacy, Sales, and Legal. Will also interact ... content management functions for all NNI internet sites Manage PRB (medical, legal, regulatory ) review of NNI internet site and its waterfall of content Manage… more
- Merck & Co. (Rahway, NJ)
- …needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... for assigned protocols and sites in a-country.-Under the oversight of the CRA manager or CRD, the person ensures compliance of study-conduct with ICH/GCP and country… more
- Merck & Co. (Rahway, NJ)
- …learn new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements Ability to multi-task, work independently, and ... the flow of data downstream for Analysis and Reporting. Interface with CDS manager /supervisor to assure consistency of technical and process strategies. Acts as a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Lead. Fosters strong collaboration with cross-functional teams, including product, marketing, field, regulatory affairs , and medical affairs , to align on ... you ready to experiment with us? The Position The Business Excellence Project Manager will be a critical driving force for execution of product marketing activities… more
- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ... This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, and Legal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand-level marketing ... cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , and channel leads to align marketing tactics with overall… more
- STERIS (Alpharetta, GA)
- …submit required documents. Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected ... Senior Manager , Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Alpharetta, GA, US, 30004 Description: At… more
- Magna (Troy, MI)
- Senior Manager , Regulatory Affairs Job Number: 61508 Group: Magna Corporate Division: Magna Services of America (Troy Office) Job Type: Permanent/Regular ... who lead us on this journey. **Role Summary** **About the Role:** The Senior Manager , Regulatory Affairs assists with the development, evaluation, and… more
- Invenergy (Denver, CO)
- …or after the 3-day posting window. Job Description Position Overview The Manager / Senior Manager , Regulatory Affairs will represent Invenergy before ... + Excellent verbal and written communication skills. Salary Range Manager , Regulatory Affairs : $100,000 - $115,000 Senior Manager , Regulatory … more
- Bausch Health (Bothell, WA)
- …to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager , Regulatory Affairs provides ... their globally distributed products. This role is not a regional regulatory but global regulatory position which under the organization of Solta Medical Inc.… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and ... to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and managing regulatory … more
- System One (Florham Park, NJ)
- Title: Manager / Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP ... Company located in NJ is hiring a Manager / Senior Manager US Regulatory Affairs - Global Development Projects with 5+ years industry experience.… more
