The Senior Regulatory Associate role will be working with regulatory operations as well as regulatory affairs on submission preparation to global regulatory authorities. Specifically, this role will work closely with the Regulatory Operations Manager and the Regulatory Leads to support day-to-day ac...
The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-...
Prepare and coordinate regulatory submissions, including amendments, supplements, annual reports, and safety reports. Develop regulatory strategies for manufacturing changes and activities. Manage workflows for regulatory submissions, ensuring they meet global standards. Bachelor’s degree in a scien...
The Associate Regulatory Affairs Manager will be responsible for completing the regulatory work for the Health and Biosciences business and applicable joint ventures, with a focus on food applications, for the U. The The Associate Regulatory Affairs Manager is responsible for regulatory document dev...
The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities. Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary ...
Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...
Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regul...
Help determine regulatory strategies for manufacturing changes and regulatory activities. Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internshi...
Help determine regulatory strategies for manufacturing changes and regulatory activities. A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with - years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship)...
The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-...
Assist in preparing product dossiers for regulatory submission to regulatory. Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements as well as development projects. You will be the primary contact and provid...
Internal regulatory support for operation and control eg:Review and approval of Lonza Regulatory Intelligence Bulletin, Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products and maintain transparency of ...
Regulatory Affairs Associate I. Help determine regulatory strategies for manufacturing changes and regulatory activities. A Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Coordinate and track workflows for regulatory submissions. ...
As part of the team that ensures our labels meet the user's needs, the Associate Regulatory Labeling Specialist will work closely with other departments across the organization, making this an entry-level position that offers a unique breadth of exposure to different medtech compliance and design fu...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research. Independently provide strategic guidance/input related to current regul...
A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks. CF; Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. CF; Partic...
A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks. Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the ...
The Compliance Specialist will collaborate with the Compliance Team and Quality/Compliance Manager to develop procedures, policies, and best practices that ensure the company operates within legal and ethical guidelines. Additionally, they will work with the Compliance team to handle customer survey...
Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...
The Environmental Compliance Specialist is responsible for coding environmental commitments from environmental and permit approval documents into the Authority’s Environmental Management and Mitigation Assessment database application (EMMA), preparing reports in EMMA to identify gaps and docum...
Responsible for reporting monthly adjustments and corrections to the Compliance Manager. ...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
The Digital Technology Manager, individual contributor, will lead the digital transformation of our Global Stewardship team, driving innovation and efficiency in regulatory processes. The ideal candidate will possess a deep understanding of digital technology, data management, and regulatory affairs...
Director of Regulatory Affairs – Body Contouring and Regulatory Innovation MPS. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China. Supports re...