- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing ... priorities and effectively delegate and assign activities to meet the business needsAbility to develop short and mid-range project plans that are realistic and effective at meeting goals.Strong analytical skills to drive operational milestones Influence… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as ... trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication… more
- Aequor (Thousand Oaks, CA)
- …align with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all required training ... with relevant team members. Implement prevention or corrective actions based on lab manager feedback. Perform QC Support tasks eg, organization and cleaning of the… more
- Twist BioScience (South San Francisco, CA)
- The QC Associate II will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with ... stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you...In this position you will report to the QC manager .What You'll Be Doing Review and release products based… more
- Merck & Co. (Durham, NC)
- …Manufacturing Division ( Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …personnel to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is responsible and accountable for the… more
- Aequor (Thousand Oaks, CA)
- …role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. Let's ... supply. With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions to mitigate against… more
- Stryker (Portage, MI)
- Stryker is hiring an ** Associate Manager , Regulatory Affairs** preferrable in **Portage, MI,** to join our **Craniomaxillofacial (CMF)** **Business!** In ... this role, you will lead and manage a team of regulatory professionals to ensure compliance with applicable regulatory requirements at the local, state, and… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam… more
- JPMorgan Chase (Brooklyn, NY)
- …governance for the CIB, responsible for enhancing transparency and senior oversight of regulatory interactions, issues, and commitments. As an Associate in the ... Join our Regulatory Commitments Team (RCT) within the Compliance &...will provide analysis, guidance, and strategic thought leadership on regulatory processes. You will ensure operational readiness for … more
- Reckitt (Parsippany, NJ)
- Regulatory Affairs & Safety Associate , HH... regulatory team. This position reports to the Regulatory Affairs & Safety Manager , Essential Home. ... you to grow in our great organisation. **About the role** The Regulatory Affairs & Safety Associate , Regulatory and Compliance provides regulatory and… more
- Abbott (Alameda, CA)
- …location in the Diabetes Division. As a manager , the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work on-site at… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and ... + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory … more
- J&J Family of Companies (Spring House, PA)
- …if approved by the Company. **We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.** **Purpose:** + Able to ... TAs independently. + Contributes to and champions internal standards, regulatory , and publishing guidelines. + Contributes to and champions...manage a subset of TA). + If a people manager : + Manages a team of internal medical writers… more
- BeOne Medicines (San Mateo, CA)
- **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent ... responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines… more
- RWJBarnabas Health (Somerset, NJ)
- …as health/business administration, regulatory compliance, accreditation or licensure associate , business development or operations manager . + Minimum three ... Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... submissions to FDA + Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting… more
- Liberty Utilities (Merrick, NY)
- Manager , Regulatory Rates and Revenue Requirements Merrick, NY, US, 11566 **Our purpose is sustaining energy and water for life, and it is demonstrated in ... jurisdictions. The Manager will support the Regional Director, on other regulatory matters and organizational strategies on a periodic basis. The Manager … more
