The Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support for Organon Network Projects. Serves as the CMC Lead for assigned Global Netw...
The Senior Regulatory Affairs Associate/Manager plays a key role in ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-soluble products) while also providing ...
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 Associate Director/Director plays a key role in developing and executing regulatory strategies and ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-solu...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
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Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Responsible for any additional duties or assignments as directed by Manager of Regulatory...
GGG is seeking a detail-oriented and self-motivated Food Regulatory Labeling professional to join our team in the Paramus, NJ office. ...
Responsible for fabricating any tolerance fixtures or gauges needed for operational or quality usage.Maintain the cleaning of all tool room equipment and machinery used to perform job functions.Keep employees on assigned tasks and deadlines.Identify training needs and provide adequate training for c...
The individual will be partnering with Regulatory Reporting Analysis team members and business stakeholders to assist with the automation efforts across all regulatory reports. Partner with Regulatory Reporting Analysis team members to understand current reporting procedures and manual processes per...
Animal Care/Use Compliance Specialist. Animal Care/Use Compliance Specialist. Additionally, this role may lead less experienced specialists and provide regulatory guidance to investigators. Maintains all related records in compliance with HMH SOPs and regulatory requirements. ...
Lead core project team and facilitate extended/complete project team leadership. Manage project resource needs and establish contingency plans. Design, implement, track, and revise project plans. Ensure project deliverables meet customer and client expectations. ...
Support the Regulatory Affairs Therapeutic Area Head for IN&F in this strategic leadership position responsible for leading and developing the global regulatory strategies, overseeing health authority interactions and for providing oversight for the preparation, review and evaluation of submissi...
The Manager, Regulatory Affairs reports into the Director Regulatory Affairs or above and is based in Morristown, New Jersey. Works with project management, development, and commercial teams and leads regulatory activities associated with planning, authoring, compiling, and submitting highest-qualit...
The Director US Regulatory Affairs supports the contract development and manufacturing of client cell therapy products for the US market. Work with the Global Head of Quality and Regulatory to plan for the long-term strategy and development of the Regulatory Affairs Department, including the develop...
Good understanding of hardware and system software interactions, and ability to apply this knowledge to resolve technical issues.Ability to view situations objectively from different perspectives.Ability to frame situations and make/drive decisions.Ability to resolve complex problems, drive for resu...
Executive Director Regulatory Affairs - Companion Diagnostics & Precision Medicine. Significant experience in regulatory affairs and diagnostic-related development (e. Experience communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership...
May represent the regulatory affairs function on Global Project Teams and be responsible for developing and implementing regulatory strategy (US and/or global) to achieve regulatory approvals and competitive product labels. Develop and direct implementation of global regulatory strategy for assigned...
Op zoek naar een uitdagende functie? YER zoekt een Assistent Project Manager in Antwerpen!. Hoboken Engineering Engineering & Development Wo Master Project sourcing via YER. Hoboken Engineering & Development Wo Master Project sourcing via YER. ...
The Segment Marketing Lead Analyst will have broad exposure to legal and regulatory compliance and the role of compliance in health care marketing, experience in managing the development and execution of marketing campaign plans, overseeing execution, and optimizing expenses. Working with the Segmen...
Are you interested in improving and shaping the delivery of IT projects industry? We’re seeking a Desktop Engineering Project Manager to oversee a Windows 11 upgrade project. The ideal candidate is required to have excellent project management skills, with experience in organizing, planning, and exe...
Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Compliance Group. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry and their impact on manufacturin...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
The Program Manager (PM) will be responsible for planning and executing logistics for professional education speaker programs and activities. Manage overall budget for each event• Database all program information and provide regular reports to the client on program status, program evaluations, finan...