Job Title: Senior Associate, Regulatory Affairs. Join our Regulatory Affairs team as a Senior Associate and contribute to our ongoing projects. Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Provide Subject Matter Expertise in Veeva Vault Configuration and...
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. ...
The Senior Associate will be tasked with the organization, management, and execution of regulatory CMC projects, ensuring the successful support of regulatory submissions. Job Title: Senior Associate Regulatory Affairs – CMC. We are seeking a dedicated and experienced Senior Associate for their Regu...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
Job Title: Regulatory Affairs Senior Associate. Join our dynamic, global team as a Senior Associate in Regulatory Affairs. You'll be working closely with our Regulatory Information Management and Systems (RIMS) team, contributing to our mission of delivering regulatory systems and processes that ens...
Someone who has good knowledge of Regulatory Affairs/Compliance. ...
Engage with quality teams, engineers, and technical experts to address and resolve regulatory issues and inquiries from regulatory agencies. Offer regulatory guidance and input to cross-functional teams, developing and implementing global regulatory strategies for various devices. Interpret and appl...
Work collaboratively to support the Regulatory Affairs CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. ...
Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. Supports all Company initiatives as identified...
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...
Senior Manager, Regulatory Affairs (Clinical). Meet has partnered with an exciting late-stage oncology biotech that is looking for a Senior Manager of Regulatory Affairs to join their team. You will support the preparation of major regulatory submissions (IND's, NDA's, BLA's). You will serve as the ...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
They are looking to bring on a Senior Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requireme...
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. ...
Senior Project Manager, this person will manage end to end project cycles, including coordinating the efforts of the JD Group Design team, Project team and third party contractors. Prior project Management experience and ability to manage multiple, simultaneous projects across a number of group fasc...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
The Compliance Analyst is responsible for auditing internal compliance reports and client documentation to determine the loan’s eligibility for purchase on the secondary market by ensuring compliance with applicable regulatory requirements including company and investor overlays. Compliance and/or Q...
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
As the Regulatory Affairs Director, you will have the opportunity to lead Allogeneic trials – the most innovative in history! This role allows you to bring past Regulatory knowledge to the table, while also be creative in strategic discussions and decisions. Regulatory Affairs experience within a ph...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. Regulatory Compliance - knowledge of federal and municipal regulatio...
Regional Compliance Specialist. Assist in turning around low-performing divisions' compliance numbers and contribute to the continuous improvement of the company’s compliance program and processes. In collaboration with Region Safety Directors, GMs, and division safety, develop and implement strateg...
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...
About the Position: Under the direction of the Director of Compliance, the Compliance Analyst is responsible for handling compliance related duties, including but not limited to HRB, MRP etc. Maverick’s team includes underwriting, risk management, compliance & legal, technology &...
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Assist Regional Regulatory Represen...