a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (G-TRL... mentorship to team members to elevate enterprise thinking and capabilities of our drug discovery talent across the global...
About This Role: The Director, Global Competitive Intelligence (CI) for Immunology leads Biogen’s CI strategy... CI into brand, portfolio, and enterprise planning cycles. Translate complex market, clinical, and regulatory signals into clear...
challenge the status quo for the better. Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group... is also a dedicated partner with global leaders in scientific research, patient advocacy and care. . Who...
of ICH and global regulatory guidelines and how they apply to drug substance manufacturing and control. Experience with phase... This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject matter expert and primary technical...
discovery programs to clinic, The Global Therapeutic Research Lead (GTRL) is a pipeline critical strategic leader responsible... enterprise thinking and capabilities of our drug discovery talent across the global Research function. As project lead, the GTRL...
the skills to build, lead, develop and work with teams and individuals in a global, functionally matrixed environment...Job Description General Summary: Vertex seeks a dynamic and experienced Medical Affairs physician executive to lead...
This is what you will do: The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head... Global Safety Head. The Global Safety Program Lead, Senior Director will operate according to the highest ethical, quality...
, successful approvals, and long-term lifecycle management. Key Responsibilities Define and lead the global CMC regulatory strategy... submissions, ensuring accuracy, consistency, and compliance with global requirements. Lead regulatory responses to health...
We are seeking an experienced and strategic Senior Director, Regulatory Affairs - CMC to lead global CMC regulatory... and lead global CMC regulatory strategies for small molecule and biologic programs (IND/CTA through NDA/BLA/MAA and post...
, communication, and influencing skills with proven ability to lead teams Excellent knowledge of global GMP requirements...Job Description: The Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence...
regulatory strategy under guidance of the Global Regulatory Lead Responsible for regulatory communications with local health... or global regulatory strategies for development and commercialization of program(s) within the portfolio. This role requires...
, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific..., join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the...
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant... and other presentations . About the Role Submission Content Manager, Regulatory Affairs Operations The Submission Content Manager plays...
Position Summary Senior Consultant - Risk, Regulatory, & Licensing - Digital Assets Regulatory & Financial Risk... for helping clients navigate complex regulatory environments and mitigate risk in the rapidly evolving world of digital assets...
market and regulatory trends, delivering insights that shape client strategy, compliance posture, and innovation. Lead...Position Summary Manager - Risk, Regulatory, & Licensing - Digital Assets Regulatory & Financial Risk Ready...
. Your work will primarily encompass: Provide CMC regulatory expertise for global development and registration programs (e.g.../CTAs, marketing registration applications, supplements and variations. Provide CMC support on the global regulatory plan...
Job Description: The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing... of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable...
to find a Senior Director of Regulatory Affairs to lead global regulatory strategy across their clinical development pipeline... strategy, and global regulatory interactions. What you'll own: Lead regulatory strategy for oncology clinical programs...
. The position reports into the Global Regulatory Lead for one or more programs. Responsibilities and Duties Submission... of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team...
Head of Regulatory Legal is responsible for developing and leading the global legal strategy supporting Global Quality (GSQ... high-level legal counsel on regulatory matters (FDA, EMA, and other global agencies), manufacturing, supply chain, and the...