trials. Responsibilities will also include regulatory strategy development for drug development for rare diseases. Manager.../ Sr. Manger, Regulatory Affairs will be the Regulatory Lead for providing technical regulatory input to cross-functional...
material from clinical to commercial. Based in Houston, the Regulatory Affairs Manager will support the site’s and customers... to commercialization Lonza is looking for an individual to provide regulatory affairs support for cell and gene therapy customers...
About the Role: We are looking for a Regulatory Affairs Product Manager to join our team with the Aortic Business Group..., submissions, and regulatory processes Work together with cross-functional teams (e.g., clinical, Product Specialists...
Your mission Pierre Fabre USA is seeking a Regulatory Affairs Manager to join our team. This role will oversee... and coordination with Corporate Regulatory Affairs, local marketing, and compliance teams. Responsibilities: Product Registration...
/ Associate Director, International Regulatory Affairs - Lifecycle Management will be an International Strategy Lead playing... a critical role within the Regulatory Affairs International department, ensuring the seamless Life Cycle Management (LCM) of key...
Responsibilities: The Senior Manager, Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC... projects for global CMC submissions with device aspects and responses to regulatory agency inquiries for Alexion's commercial...
for diversity, working mothers, female executives, and scientists The Opportunity We are seeking a Regulatory Affairs Manager... Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed...
Job Title: Regulatory Affairs Manager Job Location: Palo Alto, CA, USA Job Location Type: Remote Job Contract... test, aims to address the needs of individuals eligible for cancer screening. Job Description The Regulatory Affairs...
timely and compliant submissions and represent regulatory affairs on clinical study and execution teams. Key...Job Title: Manager, Regulatory Affairs Job Location: United States Job Location Type: Remote Job Contract...
Job Title: Sr. Regulatory Affairs Manager Job Location: Pennsville Township, NJ, USA Job Location Type: Remote... our Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites. Additionally...
of. Regulatory Affairs Senior Manager – Regional Regulatory Lead Live What you will do Let’s do this. Let’s change the world.... The Regulatory Affairs Senior Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining...
clinical portfolio. In this role, a typical day might include: The Senior Manager, Regulatory Affairs IVD will work closely... (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate...
Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives. Establish... in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline. 5-7 years of experience in regulatory affairs...
for all regulatory interactions with FDA/EMA and global regulatory authorities. Lead regulatory dossier submissions to FDA (IND, BLA... for compliant submissions. Writing regulatory documents (e.g. new BLA/NDA/INDs, briefing book content, BT Designation request...
Responsibilities: The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop... on one of the following subject matter expertise. Maintenance: preparation of selected global regulatory submissions (eg Annual...
Responsibilities: The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA... candidate will have a deep understanding of regulatory affairs related to generic drug development and dossier submission...
About the Job The Regulatory Affairs Sr Mgr is responsible for supporting the regulatory function and its activities... submission (e.g. NDA, PMA). Manage pre-market submissions for regulatory approval of data products. Manage internal...
. You will develop US and International regulatory strategies for product submissions, identifying needs for bench, animal, and clinical... activities of and provide daily direction to a team of quality professionals, including any combination of regulatory affairs...
Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post... approval changes; defines CMC regulatory submission strategies during development and post approval. Experienced with clinical...
, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance..., submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER...