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 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...
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance. Lead Regulatory Affairs and Quality Assurance functions. Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Manage all aspects of Regulatory su...
Senior Manager, CMC Regulatory Affairs, Biologics. 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, 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 ...
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...
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...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
The Executive Director/Senior Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations. Executive Director/Senior Director of Regulatory Affairs. If you or someone y...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
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...
They are looking for a Director of Regulatory Affairs with experience to spearhead regulatory strategies for Class II and Class III Cardiology and/or Cardiovascular Devices. If you would like to learn more about this Director of Regulatory Affairs opportunity and have the desire to build and develop...
The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...
With a portfolio of over 200 ongoing C&I focused PV solar projects ranging from 1 – 5MW, now increasing to 20MW with growing Solar + BESS demands, they are seeking a skilled Project Manager to add bandwidth to their team. In this role, Project Managers will oversee the full lifecycle of a project, f...
They will also effectively monitor and present project updates to relevant stakeholders, clients, or project team members. The ideal candidate will be responsible for planning, coordinating, and implementing projects within the decided-upon budget, timeline, and scope. Update relevant stakeholders o...
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...
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 ...
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...
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...
Director of Regulatory Affairs. You’d oversee regulatory filings, partner with external consultants, and eventually build out the regulatory function internally. Partner with external regulatory consultants and oversee the build-out of the internal regulatory function. This role will be pivotal in b...
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...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filin...
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. May lead the Labeling Regulatory Strategy Team (LRST), and serv...