- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… 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...areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related… more
- Aequor (Thousand Oaks, CA)
- …Key responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, ... FULLY REMOTE Regulatory Writing Senior Manager ln this...drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs ,… more
- Aequor (Thousand Oaks, CA)
- …time. Ideal candidate: In need of 5-8 YOE in project management within R&D and regulatory affairs , within pharmaceutical. Not a tech expert but they need to ... Manager - End to End Regulatory Content Automation Initiative, Global Regulatory Affairs and Strategy, Position Summary: We are seeking a seasoned Project… more
- Merck & Co. (Rahway, NJ)
- …payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through continual… more
- Catalent (San Diego, CA)
- …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego,...raw materials and finished goods release processes, customer and regulatory audits, including coordination and submission of… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support... filing strategies. Assist in preparation and review of regulatory submission to authorities. Maintain annual licenses,… more
- DivIHN Integration Inc (North Chicago, IL)
- …one of our Talent Specialists Meghna at ### Rashi at ### Title: Specialist Regulatory Affairs Duration: 7 Months Location: Abbott Park, IL/ Columbu, OH ... head of a unit/department. Accountability / Scope: As the professional in the Regulatory Affairs function, the individual will assist teams in the registration… more
- DivIHN Integration Inc (Alameda, CA)
- …and manufacturing, who are willing to look for a career in Regulatory Affairs . Interviews: 1 interview with hiring manager and then interview with manager ... to a manager or head of a unit/department. Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality,… more
- STERIS (Alpharetta, GA)
- …documents. Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected to have in-depth ... Senior Manager , Regulatory Affairs Biocides...STERIS's global business plans. This includes determining registration and submission requirements in the various markets and identifying the… more
- ICU Medical (Lake Forest, IL)
- Job Title Manager , Regulatory Affairs - Electromechanical Devices FLSA Status Exempt Work Arrangement Hybrid Position Summary The Manager , Regulatory ... and will not be discriminated against on the basis of disability. **Title:** * Manager , Regulatory Affairs - Electromechanical Devices (Hybrid)* **Location:**… more
- AbbVie (Irvine, CA)
- …https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US ... Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US ...in a scientific field, plus 6 years' experience in regulatory affairs ; or + Education equivalent to… more
- Abbott (Westford, MA)
- …peripheral stents. Our location in Westford MA, currently has an opportunity for a ** Regulatory Affairs Project Manager ** . As an individual contributor, the ... function of a Regulatory Affairs Project Manager is...the acceptability of quality, preclinical and clinical documentation for submission filing + Determine submission and approval… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , CMC Regulatory Affairs -...and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA. + ... a difference with. **How you'll spend your day** As Manager , CMC Regulatory Affairs you...timelines in order to judge the work required for submission of a quality filing + Ability to assess… more
- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs and other local and headquarter...with cross-functional departments for preparation of documentation necessary for submission of applications + Maintain up-to-date knowledge of laws,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Manager , Regulatory Affairs , you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to ... pre-market regulatory leadership to MMS-PA business + Directs premarket regulatory affairs activities which may include interactions between MMS-PA and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …submission packages, labeling revisions, and promotional materials for regulatory compliance. In addition,collaborateswith Medical Affairs regarding ... evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the… more
- ADM (Kennesaw, GA)
- **83651BR** **Job Title:** Senior Regulatory Affairs Manager - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory Affairs , Corporate ... a full-time, exempt level position. **Position Summary:** The Senior Regulatory Affairs Manager is responsible...actions as applicable. + Own the preparation, review and submission of regulatory dossiers and applications for… 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 international ... teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and managing… more
- Entergy (Austin, TX)
- Manager , Regulatory Affairs (Utility) **Date:** Apr 20, 2024 **Location:** Austin, Texas, United States **Company:** Entergy **Posting End Date:** **Work ... in an effective manner is essential. + Review all regulatory agency submission materials to ensure timeliness,...candidates for work visas for this position. **Job Segment:** Regulatory Affairs , Compliance, Law, Marketing Manager… more
