As an Associate Director of Regulatory Affairs, you will represent regulatory affairs on cross-functional teams and provide regulatory advice on clinical development matters. Associate Director, Regulatory Affairs. Regulatory Affairs, regulatory submissions, drug development, oncology, FDA, EMA. The...
This Associate Director of Regulatory CMC will directly report to the Senior Director of Regulatory Affairs, CMC, and will be responsible for representing regulatory CMC on cell therapy pipeline + products. Associate Director, Regulatory Affairs CMC. Regulatory Affairs CMC experience in a pharma/bio...
Associate Director Regulatory Affairs (Temp to Perm). Oversee regulatory submissions and approvals, ensuring alignment with global regulatory standards. Lead regulatory strategy development and execution for both U. Collaborate with stakeholders to establish project timelines and regulatory goals. ...
As a Senior Associate of Regulatory Affairs, you will support Regulatory Affairs management in the day-to-day operational aspect of the department and support interactions with global regulatory authorities. Senior Associate, Regulatory Affairs. Represent Regulatory Affairs on project teams and clos...
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. ...
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...
Director of Regulatory Affairs, you’ll take the helm of regulatory submissions and strategic planning for successful drug approvals across key markets, including the FDA, EMA, and other regulatory agencies worldwide. Are you ready to lead regulatory strategies that bring innovative therapeutics from...
Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Experience with Japa...
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...
This Senior Director/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. Senior Director/Director of Regulatory Affairs. Regulatory Affairs experience in a pha...
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. Minimum of 5 years of experience in medical device Regulatory Affairs with a deep understanding of regulatory frameworks. As a key player in regulatory over...
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 ...
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...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. The Senior Manager will collaborate closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders (consultants, CRO...
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. ...
As the Director of Regulatory Affairs, you will be a pivotal leader within the company, driving strategic regulatory decisions across the entire portfolio. Director of Regulatory Affairs. You’ll co-lead a growing regulatory team, and play a key role within regulatory submission and strategy. Regulat...
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...
Business Affairs Manager to our team in either NC, NY or LA. Provide business affairs support for CYLNDR internal productions, issue contracts, purchase orders and handle any other business affairs needs. Manage business affairs needs for assigned accounts for integrated commercial, promotional, exp...
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...
Our partner, a leader in innovative biopharma resources and patented ingredients, is seeking a Regulatory Affairs Specialist to join their Los Angeles team. This role offers a chance to contribute to groundbreaking developments and regulatory processes with a global impact. Develop and support regul...
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...
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 ...
Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc. Previous APAC regulatory experience in the medical device or pharmaceutical industries. ...
Project Managers (levels I, II, and/or III). Licensed professional or Certified Construction Manager (CCM) or PMP. Work experience in project planning and development. Ability to independently manage all aspects of a project. ...
Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Must have 1-3 years of experiences in Medical Device Regulatory Affairs. Assist the strategy implementation and operations for regulatory affairs activities, product registra...