REGULATORY STRATEGY AND SUBMISSIONS jobs in ENGLAND EUROPE, United Kingdom #3

will include defining the regulatory strategy, plans, and objectives for assigned products or projects. Additionally..., you will oversee the preparation and maintenance of CMC regulatory submissions for assigned products or projects, guiding and advising...

. Finally, this role works with cross-functional areas to determine the appropriate strategy for labels for regulatory authority... and efficient promotional review process. Partner with Global Regulatory Strategy and Labeling on future/planned labeling updates...

and strong collaboration with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling.../APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory...

with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling Operations...Title: Associate Director, US Regulatory, Advertising & Promotion Company: Ipsen Biopharmaceuticals Inc...

development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects... for products and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs) Responsible...

, IMPDs, MAAs). Develops and implements regulatory strategy and executional plans and manages regulatory submissions (e.g... strategy, lead development of regional regulatory documents and meetings and provide regulatory advice on regional regulatory...

Party / BD). Perform any other regulatory activities as required by company strategy. Every day, we rise to the challenge... administrative and regulatory support to the regulatory teams to enable dossiers to be submitted within agency or departmental...

to join a team of experienced actuaries to lead the regulatory reporting and submissions for the Reinsurance Business Group at AXA XL... and responsible for annual actuarial reserving reports and regulatory submissions. Support the analysis needed for the statutory...

with Amgen’s corporate standards. Your responsibilities will include planning and managing EMA regulatory submissions... execute the filing plan for the EMA Ensure regulatory submissions are made on time and meet Amgen’s corporate and local...

timely regulatory compliance with above approvals. Advise the Global team on regional considerations in developing strategy... regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans...

for submission in the relevant countries. Manage strategy and execution for all regulatory CMC submissions (e.g. late stage clinical... regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified...

interactions consistent with the Global Regulatory strategy- including contingency regulatory planning/risk assessment. Plan... and manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans...

Reference Number: JO-2404-533971 Regulatory Coordinator Rate: Negotiable Job Type: Contract Location: Reading... Job Title: Regulatory Affairs Coordinator CTA, CTR (Consultant) Job Type: 12 Month Contract Location: Berkshire, UK – Hybrid...

within S&P Global Market Intelligence, Regulatory Compliance Division. This position will report into the of Commercial Head... Managed Services but work closely with the Sales, Operations, Technology / Product team across Regulatory Compliance...

compliance with applicable legislations. To develop the regulatory strategy for new submissions. Working on EU projects...Regulatory Affairs Manager - Leading Pharma Specialist Medicines - Manchester (hybrid working) - £competitive salary...

closely with the Strategy and Regulation team to deliver technical and commercial submissions at the price review...Job Description As the Asset Strategy Director you'll be responsible to turn business vision and strategy...

on time, overseeing the Planning Strategy and Implementation Team, and supporting various projects in South Essex. The..., regulatory and best practice requirements and guidelines. The postholder will lead and manage the work of the Planning...