Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory ...
You will report to the Senior Director of Regulatory Affairs CMC and be part of the Regulatory Affairs CMC team consisting of 8 experienced and dedicated colleagues. Director/Associate Director, Global Regulatory Affairs - CMC. The project portfolio at Genmab is evolving, and we are therefore lookin...
Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketi...
Join our dynamic and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you will utilize your knowledge and experience to build a stronger Regulatory Operations team by providing guidance, as well as regulatory system and process support for th...
Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...
Train and obtain access on company tools and systems that support contracting, PO, and invoicing for regulatory affairs in the US and EMEA. In this role you’ll be working with cross-functional teams to assist with the coordination and completion of international regulatory documents. This role will ...
Pharmaceutical company looking for an experienced Quality Assurance and Regulatory Affairs Associate. Ideal candidates should have experience within QA and/or Regulatory Affairs department in a pharmaceutical or R&D company. Under the supervision of the Head of QA/RA, the QA/RA Associate is responsi...
On-Board Scientific is hiring a Regulatory Affairs Assistant!. The Regulatory Assistant needs to exhibit working knowledge of pharmaceutical operations. The Regulatory Assistant will need to utilize scientific and technical information to ensure that documents produced are consistently accurate and ...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Ability to interpret Regulat...
This role is the key in ensuring the accurate and the timely submission of all Guerbet regulatory documents, staying current on all US federal regulations to ensure compliance, develop training programs and/or communications documents to meet regulatory requirements, and ensure that regulatory proce...
Program Manager, Commissioning. Reporting to the Program Executive, Office of Capital Projects (OCP), manage the Quality Control/Quality Assurance responsibilities associated with Facilities Capital Project execution. Construction Manager and/or subcontractor compliance with specified quality contro...
A company is looking for an ERP Project Manager to oversee updates and changes to their ERP systems. ...
A company is looking for a Regulatory Consulting Associate responsible for preparing plan documents and providing regulatory compliance support. ...
A company is looking for a Trade Compliance Specialist to provide analytical and organizational support related to customs and trade compliance. ...
A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
A company is looking for an Associate Regulatory Operations Specialist (Remote). ...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
Key Responsibilities:Develop and implement regulatory strategies for global medical device clearances and approvalsManage regulatory submissions and communications with FDA and EU notified bodiesProvide regulatory guidance to cross-functional teams throughout the product lifecycleRequired Qualificat...
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
A company is looking for an External Affairs Program Manager to develop and lead policy and legislative strategies. ...
Chemistry; advanced degree is a plus6+ years of pharmaceutical industry experience in CMC Regulatory Affairs, with a focus on small moleculesExperience in leading high-quality CMC regulatory submissions for global marketing applicationsStrong knowledge of global regulatory guidelines (FDA, EMA, ICH)...
A company is looking for a Complaints Program Manager to oversee its regulatory complaints program in the AMER region. ...
A company is looking for a Senior Program Manager to oversee project delivery and stakeholder engagement in a remote setting. ...
A company is looking for a Project Manager, Commercial to support the growth of their Commercial Sales segment. ...