Tim Powell

Director - Submission Sciences & Regulatory Systems, Process and Intelligence @Biogen

Maidenhead, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2022 — Present

Director - Submission Sciences & Regulatory Systems, Process and Intelligence @Biogen

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Maidenhead, GB

EDUCATION

1999 — 2003

University of Birmingham

BSc (Hons), Chemistry with French

2001 — 2002

Ecole Nationale Superieure de Chimie a Montpellier

Chemistry

1993 — 1999

RGS High Wycombe

Maths, Physics, Chemistry, French A-Levels

SKILLS

CmcStandard Operating Procedure (Sop)Regulatory SubmissionsRegulatory RequirementsIndClinical DevelopmentRegulatory AffairsPharmaceuticsClinical TrialsRegulatory OperationsEctdPublishingEmerging MarketsBiotechnologyPharmacovigilanceGmpDocumentumElectronic Common Technical Document (Ectd)Pharmaceutical IndustrySop

ABOUT TIM POWELL

18+ years of experience including regulatory technology & innovation, shaping the future of regulatory operations, managing teams of Global Delivery Managers and coordinating and building the whole spectrum of regulatory submissions.I have a wide knowledge base including a great deal of technical experience relating to eCTD / NeeS / electronic dossiers and how these are evolving into new paradigms (documents -> data, use of cloud technology, structured data), as well as a strong focus on strategic planning and working efficiently and collaboratively with stakeholders.I am experienced in regulatory systems implementation and setting a strategic roadmap of systems and data management, as well as knowledgeable on development of global regulatory strategies. I chair the EFPIA eCTD subgroup, am the deputy topic lead on the ICH M8 expert working group and stay up to date with current trends and upcoming / new regulatory guidelines to keep our business ready and prepared for change.I am looking to continue building my leadership skills and take on additional responsibility.

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Tim Powell — Director - Submission Sciences & Regulatory Systems, Process and Intelligence at Biogen in Maidenhead, GB | Unifers