Regulatory affairs manager cms , uk/ eu - united kingdom, marlow, buckinghamshire

job purpose

provide regulatory leadership, strategy, and tactical support for assigned investigational through post-approval projects; represent cmc regulatory affairs on global project development teams as needed and regulatory affairs functional teams; remain current on regulatory requirements for relevant countries, particularly us, canada, and eu; demonstrate excellent interpersonal skills and the ability to lead multiple tasks

the role:

support developing and creating global cmc regulatory strategies for multiple clinical development projects at all stages (phase i through post-approval).

support authoring and / or review regulatory cmc documents for submission to us, eu, ca, and/or other regulatory agencies in support of formal meetings with health authorities and major applications (inds / ctas, ndas / blas, maas, pas, etc.

support the preparation and conduct of formal cmc-focused meetings with regulatory health authorities including the review of applications and negotiations with health authorities.

create and maintain the cmc portion of the global regulatory strategy document and provide strategic cmc input to global project development plans.

identify and escalate potential regulatory issues to management, conduct risk evaluations, and propose mitigation strategies.

develop and manage submission authoring, review, and submission timelines.

research regulatory requirements to support cmc submissions or inquiries from functional groups.

lead regulatory-cmc intelligence process and remain current on changes in regulatory requirements and environment and be a resource to functional groups for regulatory information.

manage cmc related change controls and cmc sections of annual reports to ensure regulatory compliance.

qualifications:

education:

ms/bs/ba degree, advanced degree preferred pharmd or phd

experience:

strong experience in pharmaceutical development

demonstreable expertise in regulatory affairs-cmc

highly motivated and great attention to detail.

strong endurance to work under tight timelines and complex/ changing situatons.

excellent presentation and communication skills.

thinks strategic and can demonstrate leadership

technical skills:

proficient in ms office suite.

non-technical skills:

highly motivated and great attention to detail.

strong endurance to work under tight timelines and complex/changing situations.

excellent written and oral communication skills.

excellent problem-solving skills.

broad level of interpersonal skills and flexibility.

cultural sensitivity and ability to develop consensus within a multinational organization


Kyowa Kirin International
United Kingdom, Marlow, Buckinghamshire
2022-08-19
2022-09-18
FULL-TIME
1918914
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