GLOBAL REGULATORY LEAD jobs in RAHWAY NJ, United Kingdom

review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead... Regulatory Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects...

for antimicrobials, MRL etc.) Lead development and execution of global product and project regulatory, strategy(ies) for assigned... as per guideline. Knowledge of relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications. Ph...

market assessments, lead the tumor HTA and reimbursement and execution, build the global plan for access and endorse the... to support inline and near term launches - build and lead with the Global Plan for Access for the specific tumors Provides...

Job Description The Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus...). The incumbent will be expected to lead multiple programs including those new to the organization therefore requiring...

Recognition or Decentralized Procedure. Drives labeling strategy in partnership with the Global Regulatory Team Leader in line... Regulatory Lead (GRL), Safety Management Team Lead (SMTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead...

, Universities Sodexo is currently seeking a Global Quality & Compliance Director join our based in Rahway, NJ and a portfolio... and comply with requirements defined in the global quality agreement Management and support of a robust self- assessment program...

. Responsibilities: Leadership and Management: Lead the global teams responsible for delivery and governance of SAP Project Systems... as well as Enabling Functions. The EIT SAP Platform Team is responsible for our Company's SAP Global Template asset, delivering...

development and worldwide regulatory submissions. Lead a team of statisticians and the statistical programmers to ensure... experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval...

to ensure that methods are validated to current regulatory standards and implemented at their designated testing sites... approach across all programs. Bring energy, knowledge, and innovation to carry out the following: Take the lead in creating...

drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory, Statistical... experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval...

requirements through exceptional project management. The incumbent will lead cross-functional teams for projects that may include... establishing new sources of supply for registered materials or managing a portfolio of complex process changes with regulatory...

cross-functional teams to adopt such strategies. Finally, you maintain a comprehensive understanding of global regulatory... expectations and contribute to regulatory documents and interactions with agencies. The Associate Director is a skilled modeler...

, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre... execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs...

management protocols and adhering to regulatory requirements Required qualifications, capabilities, and skills Minimum of 1... to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity...

Participate in or lead 1) development of robust and scalable upstream processes for biologics in different stages of clinical... development, 2) process characterization and regulatory filings for successful commercialization Advance upstream processes...

and loyalty for the Bravecto and Sentinel portfolio of $500M in the US. He/she will lead the development and implementation... will lead and manage the brand messaging, internal and external communications including all marketing, advertising, product...

Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents...: Ability to influence regulatory strategies including independently formulating registration packages to support global filings...