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...
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 ...
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...
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 ...
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...
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...
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...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
As an AV Events Program Manager you will oversee the portion of Audible’s event portfolio that require AV components. In this role, the AV Events Program Manager is the primary point of contact for assessment, planning, and operational management of AV events. As an AV Events Program Manager, you wi...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Summary:Program Manager is responsible to support & manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for SUN pharma. Area of Responsibility:Coordinate, Support & Align with Senior Program Leads on the Overall La...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Summary:Program Manager is responsible to support & manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for SUN pharma. Area of Responsibility:Coordinate, Support & Align with Senior Program Leads on the Overall La...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
Regulatory Compliance Specialist (14450840). Senior Regulatory Compliance Specialist. Senior Regulatory Compliance Specialist. Supplier Quality, Regulatory Compliance, DEA, and QMS. ...
As a Compliance Specialist, you will be responsible to review new DBE applications and make recommendations regarding the applicant firm’s eligibility to participate in the DBE Program. Prepare a Certification Recommendation Report based on all information which has been reviewed and is an eva...
The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. The Associate, Regulatory Labeling reports into the...
The DEA Specialist will report to the Head of Quality and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality and Compliance. We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relent...
Lead the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables to the GPTs. Present regulatory strategies including communication of regulatory risks and associated mitigation plans to ...
Compliance and Regulatory Specialist. BCForward is hiring for highly motivated Senior Regulatory and Compliance Specialist in Somerset, NJ. Title: Senior Regulatory and Compliance Specialist. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertai...
The requirement is for 3 Regulatory Affairs Specialist. The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to re...
Assistant Survey Project Manager. Candidates can expect to work on a wide variety of survey projects in different sectors such as commercial, transportation, environmental, industrial, institutional, and energy projects. Be a part of a growing group of survey professionals working on a wide variety ...