cmc regulatory

pHeadcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA. /ppThe...

pMonte Rosa Therapeutics seeks a seasoned Associate Director of CMC Regulatory Affairs to shape global CMC strategy and author critical submission content. You will collaborate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure compliant, high-quality filings. /ppYou will drive Module 3 content, quality...

pMonte Rosa Therapeutics, Inc. is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing and Controls. /ppYou will author Module 3 submissions, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and represent CMC in health authority...

Monte Rosa Therapeutics, Inc is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for Chemistry, Manufacturing, and Controls across development stages. You will author Module 3 content, review summaries, and partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

Sintetica, founded in 1921 and based in Mendrisio, Switzerland, seeks a CMC Senior Specialist to manage CMC activities for drug product registrations, lifecycle management, and regulatory compliance throughout the product lifecycle. You will prepare and maintain CMC documentation and serve as the focal point for regulatory interactions.Reporting to the CMC...

pCSL is seeking a Regulatory Affairs leader to define global CMC strategies for biological and non-biol products, partnering with RD, Manufacturing, Quality, and Regulatory Affairs to ensure compliant lifecycle management. /ppYou will author and review regulatory submissions, manage change controls, and maintain strong regulator relationships to support...

CSL is seeking a Regulatory Affairs leader to define global CMC strategies for biological and non-biol products, partnering with RD, Manufacturing, Quality, and Regulatory Affairs to ensure compliant lifecycle management.You will author and review regulatory submissions, manage change controls, and maintain strong regulator relationships to support timely...

pCSL is seeking a Senior Manager Global Regulatory Affairs CMC to lead global regulatory strategies for biological and non-biological products. You will collaborate with RD, Manufacturing, Quality, and Regulatory Affairs to deliver compliant CMC submissions, assess change controls, and influence regulatory policy while guiding external interactions with...

CSL is seeking a Regulatory Affairs leader to define global CMC strategies for biological and non-biol products, partnering with R&D, Manufacturing, Quality, and Regulatory Affairs to ensure compliant lifecycle management. You will author and review regulatory submissions, manage change controls, and maintain strong regulator relationships to support timely...

The Senior Manager Global Regulatory Affairs CMC - Biological Non-Biol. Products is responsible for: Partnering closely with CSL’s RD, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the...

Partnering closely with CSL's RD, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.Defining global regulatory strategies, objectives, and policies that advance...

OverviewMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This...

pMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This...

We are looking for a Technical & Regulatory Writer to support the preparation of scientific and regulatory documentation related to pharmaceutical analytical development. The role involves translating analytical data and technical information into clear, accurate, and compliant documentation for pharmaceutical development and regulatory submissions. Key...

ph3Director, Regulatory Affairs CMC Europe /h3 pReady to lead the CMC regulatory strategy for novel small-molecule therapies in oncology? /p pWe’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies. As the pipeline progresses towards global registrations, we’re looking for an...

pYou will oversee a part of the CMC development activities and GMP manufacturing for our innovative bi-/multi-specific antibody programs, working closely with CDMOs, CROs, and cross-functional internal teams to ensure successful delivery of development milestones. /p pbKey Responsibilities /b /p ul liLead a part of the CMC development activities including...

You will oversee a part of the CMC development activities and GMP manufacturing for our innovative bi-/multi-specific antibody programs, working closely with CDMOs, CROs, and cross-functional internal teams to ensure successful delivery of development milestones. Key Responsibilities Lead a part of the CMC development activities including Cell Line...