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...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
Coordinate regulatory activities with internal teams and external regulatory agencies. Proven experience in leading regulatory submissions and managing regulatory projects. Oversee the day-to-day functions of the regulatory initiatives for Hassen Implants, Digital, and Biomaterial Solutions. Develop...
The Documentation Specialist will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. Provide support to the Regulatory Operations team. ...
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 ...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory asse...
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,...
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...
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. ...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
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. ...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
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 ...
Regulatory Affairs Specialist (Medical Device). Zing Recruiting, in partnership with an established medical equipment manufacturer stationed in Parsippany, New Jersey is on the search for an experienced Regulatory Affairs Specialist to join their team. Regulatory Affairs Specialist Responsibilities....
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...
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...
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...
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...
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...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...
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. ...