REGULATORY STRATEGY AND SUBMISSIONS jobs in ENGLAND ENGLAND, United Kingdom #5

-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC... regulatory requirements for Biologics Develop, implement and execute a smart sourcing strategy Deep and broad knowledge...

/management of development of assays for CDx use. Experience in supporting diagnostic development and regulatory submissions... for defining the global bioanalytical development strategy and leading all activities related to clinical bioassays/diagnostics...

, supporting the business' growth strategy through the effective execution of the work winning process. Regulatory & Public... strengthen, our bids Liaising with knowledge managers to understand key USPs and highlight them accordingly in our submissions...

to company guidelines, underwriting rules and guidelines, regulatory requirements, internal controls and best practice Support... best practices, Group Underwriting Guidelines updates, and regulatory changes Assist in underwriting file reviews to ensure...

of current and changing U.S. and global regulatory requirements impacting tax due diligence, withholding and reporting Lead... discussions with clients and prospects, including coordinating peer to peer sessions on regulatory obligations, compliance...

Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects... and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca...

testing solutions, customisable testing systems, vehicle engineering, homologation, regulatory advice & expertise... and responsibilities of this position include: Influencing the strategy & execution of the business plan for the cluster Providing...

regulatory opex submissions, ensuring clear documentation and effective collaboration across business teams. You'll also help... is prioritised, thereby positively impacting business performance and strategy. As the main point of contact for business...

all areas of commercial law. To find out more please visit In order to comply with regulatory and client requirements, Ashurst... with our legal and regulatory obligations. Department / Role Overview Ashurst's Markets & Growth (M&G) team is located in major...

the organisations core values of visibility, responsiveness and trust, and organisational strategy. Conduct and review...-monthly QHSE Representatives Meetings. Ensure the availability of required QHSE data for tender and PQQ submissions. Liason...

and operational losses. Device risk mitigation strategy by co-ordinating with other business areas Deliver Daily Management... appetite and limits, reporting any violations of operational and regulatory activities. Reviews and challenge processes...

develop and implement the design strategy. Your role will involve managing the design process to ensure it meets project... and/or coaching team members is desirable. Numeracy and bid/report writing. Know what good looks like in bid submissions and work...

solvency capital requirements, in line with local regulatory regimes, reflecting the various risk profiles of the business... outputs, including solvency capital requirement submissions, whilst contributing to wider strategic initiatives related...

Partner with Financial Control to deliver robust results, and support relevant regulatory reporting submissions Prepare... is a good understanding of their performance, strategy and risks and opportunities within the Group. Foster collaboration...

with technical risk assessments (FMEA) and control strategy development. Good knowledge of QbD as presented in regulatory dossiers... milestones from candidate selection through commercialisation in accordance with regulatory guidance. In partnership...

that transactions, regulatory submissions and queries are completed inline with required timescales and legislation Leading... and resolution of any escalated issues Managing relationships with stakeholders to ensure broader strategy is understood...

that transactions, regulatory submissions and queries are completed inline with required timescales and legislation Leading... and resolution of any escalated issues Managing relationships with stakeholders to ensure broader strategy is understood...