The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) g...
Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's products and processes. Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems. Assist with preparing high ...
Internal Job Title: Regulatory Affairs Associate II. Canada Chemical regulatory oversight and review. Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. ...
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...
The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) g...
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. ...
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...
This person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. Regulatory support of new and existing products including the preparation of A...
The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) g...
Senior Principal Regulatory Affairs Specialist. Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph,...
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...
The Senior Specialist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required fo...
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 mat...
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the pr...
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...
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...
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...
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 ...
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...
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...
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...
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...