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The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
Adecco is seeking a skilled Senior Regulatory and Compliance Specialist to support global regulatory compliance within the pharmaceutical industry. This role offers high visibility, working across various functional areas including Supplier Quality, Regulatory Compliance, DEA, and QMS. Prepare the s...
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
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...
Site Start-Up & Regulatory Specialist II. Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or h...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
POSITION REQUIREMENTS: Education & Experience: • A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function...
Seeking a highly energetic and motivated individual to bring Regulatory expertise to an International Cosmetics Regulatory and Safety group supporting R&D to deliver fast-paced Beauty Care products to the market. Regulatory approval of cosmetic formula and artwork. Regulatory approval of raw materia...
Job title: Sr Compliance and Regulatory Specialist. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role ...
Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures, processes, promotional task assignments into windchill and assigned training. Provide Regulatory support in Manufacturing Plant Transition Project, Quarterly...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
The Regulatory Compliance Specialist will contribute to our organization success by ensuring the organization adheres to legal and relevant regulatory requirements by partnering cross-functionally with internal and external partners. Support the maintenance of regulatory files and internal tracking ...
Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. Develop regulatory strategies for new products with the guidance of Regulatory...
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
Senior Regulatory and Compliance Specialist. The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has hig...
Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Ea...
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. Additionally, this role leads the developm...
Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instru...
Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence. The Regulatory Affairs Specialist coordinates, fa...
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...
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 regula...
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. This role has high visibility within the Somerset site and the...
Compile, prepare, and review regulatory submission to US and EU. Anticipate regulatory obstacles and emerging issues throughout the product submission. Provide regulatory input for responsible countries/region for product lifecycle planning. Monitor applications under regulatory review and communica...
Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...