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Regulatory Manager
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Support, Product lifecycle management
Projektbeschreibung
* Have Knowledge of all current and future trends in global regulatory changes that may impact product development, and/or marketing.
* Collect, analyse and interpret data to influence and/or support future project decisions.
* Interpret all applicable regulations and information to provide a regulatory recommendation to the product/ project manage team.
* Identify, minimize and manage risks linked to a project and their influence on other projects/products/activities, produces detailed project plan to Monitor progress and keep project on track.
* Successfully be able to drive and communicate regulatory position based on regulation / industry precedence within business unit/region and externally to health authorities.
* Serve as principal spokesperson for the division, group, company or corporation on highly significant matters and participate in top level development and management of division, group, company, or corporate wide policies.
* Act as key business partner within enterprise that provides strategic advice to senior management and enables critical business and ethical decisions and minimize global business risks
* Strong understanding of product lifecycle management requirements
Directly manages;
* RA Associate x 2 (UK)
* RA Specialist (RUS/CIS)
* RA Admin (TR)
* RA Manager SAF (Indirect dotted - Primary Pharma)
Key skills / Experience;
* Bachelor's degree in science or health related field.
* Advance degree preferred
* In-depth understanding of regulatory function with general knowledge of related areas/functions
* knowledge of applicable standards
* 5-9 years Regulatory experience, including leading and preparing international submissions
* Experience preparing submissions for UK Notified and Regulatory bodies.
* Project Management not essential but would be a plus.
If you feel you have suitable experience, know someone who has, or would like to discuss the role further, please contact Joseph on 02077587322, or email on
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
City Of London, London, Vereinigtes Königreich
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges