A company is looking for a Senior Manager, Regulatory Affairs IVD & CDx. ...
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...
A company is looking for a Regulatory Affairs Manager 1 to oversee regulatory compliance and project management in nutrition, health, and beauty sectors. ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. We are seeking a Senior Manager, Regulatory ...
A company is looking for a Regulatory Affairs Program Manager to lead program and operations management for regulatory affairs. ...
The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. Function as a Regulatory A...
Maintain single source of truth for status of all Regulatory roles being hired in India throughout recruitment, transition, and sustainment phases . Coordinate activities with Accenture and Regulatory transition team being built in India. ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
The Manager, Regulatory Affairs provides support pertaining to regulatory affairs related to the development of novel drugs including preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. Interacts with the Regulatory, Clinical...
Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. An in-depth knowledge of ICH and regional CMC regulatory requiremen...
Regulatory Affairs Manager Location - Sunnyvale, CA Full time Salary - $100k - $150k + Benefits Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving...
Preparation/Review of Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs. Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications. Participate in project calls with ...
As a Regulatory Affairs manager, you will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. Regulatory Affairs, FDA, regul...
Alternative Education and Experience Requirement: Bachelor’s degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/Compliance, Biology, Chemistry, or related field of study plus 8 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Af...
Regulatory Affairs Specialist/Manager will oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices. Regulatory Affairs Specialist / Manager. A minimum of 5 years of experience in medical device Regulatory Affairs, sho...
Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. CMC regulatory activities and related regulatory initiatives. Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends,...
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. Associate Regulatory Affairs Manager. Update Registration List to communicate the statu...
The Manager of International Regulatory Affairs will be responsible for overseeing all regulatory aspects of devices marketed and sold in international markets, with a specific focus on OUS, Japan, China and Korea. Manager, Regulatory Affairs, International. Minimum of 8 years of experience working ...
Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Acts as a regulatory representative on core product developme...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
The Regulatory Affairs Manager will plan, track, and manage complex regulatory projects. The role will be directly responsible for crafting thorough regulatory strategies and compose comprehensive regulatory submissions, ensuring adherence to applicable regulations and standards. Additionally, the r...
We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa Clara, CA location. In this role, you will be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and submissions to the FDA, Notified Bodies, and other w...
Biogen company, is seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). Combination of the following can be considered: PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS ...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. Regulatory Affairs in the biotechnology or pharmaceutical industries. Manager will coordinate activities ...