on , , , , and . Job Description The Senior Manager, RA Global Regulatory Strategy US and Canada is responsible for the development and implementation... indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director...
minded Manager to support the U.S. Medical Affairs HIV Treatment Strategy team. This role offers early career visibility... and stakeholders. Ensure deliverables move efficiently through Medical Affairs and legal/regulatory processes. Cross-Functional...
of AI to improve clarity, speed, and quality of work. What You'll Do The Executive Director, Regulatory CMC provides strategic... partners closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC...
, US Regulatory Affairs Global Strategic Labeling will lead and oversee the development of end- to- end (e2e) labelling process... required for marketing registration that aligns with Organizational business strategy and regulatory requirements. Ensures effective...
, US Regulatory Affairs Global Strategic Labeling will lead and oversee the development of end- to- end (e2e) labelling process... required for marketing registration that aligns with Organizational business strategy and regulatory requirements. Ensures effective...
achieve our goal of delivering meaningful therapeutics to patients. The Director, Clinical Regulatory is a highly motivated.... The Director, Clinical Regulatory, is accountable for leading and overseeing global Health Authority interactions, project...
for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs... Regulatory Leader in Global Regulatory Affairs will be responsible for the development, implementation, and maintenance of global...
achieve our goal of delivering meaningful therapeutics to patients. The Associate Director, Clinical Regulatory is a highly... neurodegeneration. Key Accountabilities/Core Job Responsibilities: Accountable for developing regulatory strategy for complex...
leadership in defining a comprehensive science-based, solution-oriented global regulatory development strategy for assigned..., scientific and competitive environment. Represent Global Regulatory Affairs on assigned core product development teams...
Director, Regulatory Strategic Writing to lead, plan, author, and manage high-quality clinical and regulatory documents... Associate Director of Regulatory Strategic Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge...
. Description: The Senior Director/Director, Regulatory Operations is responsible for ensuring the publishing, electronic submission... collaboration with the Regulatory Strategy Leads, plan for and timely deliver regulatory documents compliant with eCTD publishing...
Role Description Your Role: The US Regulatory Advertising and Promotion Director oversees and guides the development... office. Your Responsibilities: Act as a key regulatory affairs expert within the LMR team, providing expertise...
SVP of Quality and Regulatory Affairs, the Director provides focused oversight of quality systems within CCS to ensure...Responsibilities: The Director, Quality and Regulatory Compliance (CCS) leads quality, compliance, and regulatory...
plans. The Director, US RRL is accountable to provide US regulatory strategy leadership, leveraging their expertise... Director, US Regional Regulatory Lead (US RRL) contributes to innovative, label focused, aligned US and global development...
About This Role: As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve... Delivery Solutions team, you will have end-to-end accountability for defining and executing CMC regulatory strategy...
to ensure integrity and patient safety across development business partners, including Regulatory Affairs (GRA), Global Patient... are determined to make life better for people around the world. Purpose: The Sr. Director of the Global Medicines Quality...
from chronic management to single-course gene editing medicines. Position Summary: The Associate Director, Regulatory CMC... regulatory strategy including the preparation and submission of regulatory applications in a phase-appropriate manner. Manage...
solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Director, Regulatory... in regulatory affairs, pharmaceutical industry knowledge, and leadership skills will be crucial in driving the organization...
closely with Quality, CMC/Regulatory Affairs, Manufacturing, Supply Chain, R&D, Clinical and Corporate Compliance to ensure... operating companies in 60 countries. Position Summary: Reporting to the Vice President, Innovative Medicine Regulatory...
, and maintaining a robust compliance program. The position partners closely with Quality, Supply Chain, Regulatory Affairs, R...-functional teams (Quality, Manufacturing, Supply Chain, Clinical, Regulatory Affairs, Pharmacovigilance) advising on regulatory...