REGULATORY STRATEGY AND SUBMISSIONS jobs in UNITED KINGDOM ENGLAND, United Kingdom #2

product development. Competent in addressing critical issues, providing regulatory strategy and advice, and making informed...Regulatory CMC Director - for leading Biotech with billion dollar blockbuster launch Following the successful phase 3...

of the regulatory submissions meets ICH and regional/local regulatory requirements. Perform CMC regulatory submissions... identification of CMC risk areas and development of alternative courses of actions. Contribute to regulatory strategy and filings...

and build expertise in regional regulatory requirements to ensure compliance of CMC submissions Support the agreed strategy... regulatory strategy relating to the development, manufacture and testing of all of our medicines. With our expertise...

Regulatory Strategy Provides strategic regulatory input and technical guidance on global and/or regional regulatory... RA resources, development program requirements and risks. Prepares and submits regulatory submissions...

Regulatory Strategic Team (RST) for assigned projects. This role will be accountable for the global regulatory strategy... timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the...

Products to provide global regulatory CMC strategy and guidance for combination products, platform devices and assigned... Device Regulatory Affairs CMC Director is also responsible for maintaining and updating internal platform device strategy...

. Prepare regulatory submissions to stakeholders such as the CAA and airlines. Keep up with other regulatory regimes..., and their implications for Heathrow and the regulatory strategy Qualifications: Extensive experience ideally with a business, economics...

, with a strong understanding of legal compliance, regulatory submissions, and interactions with regulatory authorities. Experience working cross... and procedures to ensure ongoing compliance with relevant laws and regulations. Manage regulatory submissions and interactions...

and national regulatory strategies based on registration requirements, product knowledge and company strategy. Maintain oversight... and provide regulatory insight to optimise the regulatory strategy in relation to the product lifecycle. Partner with the...

most efficient way. This will encompass Regulatory strategy planning, supporting due diligence assessment for any innovative assets... sources Use of electronic portals for dossier submissions; Good working knowledge of Regulatory IT systems...

Are you looking for the next step in your regulatory career that will give you ultimate autonomy over your role... and where you can develop a young Regulatory team? Would doing that for an exponentially growing Medical Device company with massive...

professionals, working strategically whilst remaining operational to spearhead regulatory strategy development and drive regulatory... of Regulatory & Clinical Affairs to be based in the UK. You will be leading an experienced team of regulatory and clinical...

the regulatory strategy, plans and objectives for assigned products or projects. You will lead Regulatory Submissions... Regulatory Lead across multiple approved marketed established products or other programs. You may lead Regulatory Submissions...

regulatory strategy for the UK. Ensuring full regulatory and company compliance, and provide regulatory expertise to support... to licensing, regulatory changes, and submissions to MHRA. Contributing to a Brand Team representing Regulatory Affairs...

. You will design, build, implement, and sustain world-class regulatory affairs recommendations, decisions, and submissions... strategy is in alignment with company objectives. Create comprehensive regulatory strategies. Develop and prepare product...

professionals, working strategically whilst remaining operational to spearhead regulatory strategy development and drive regulatory... of Regulatory & Clinical Affairs to be based in the UK. You will be leading an experienced team of regulatory and clinical...

needed for submission Develop and amend the EU regulatory procedural timelines in alignment with the regulatory strategy and commercial... and track activities related to regulatory submissions in the EU. Track and inform of regulatory submission dates, regulatory...