Global Regulatory Publishing Associate
Global Regulatory Publishing Associate
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Job Description
Band
Level 3Job Description Summary
Ensures a controlled documentation system record retention and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and nontechnical documentation change system. Assures procedures are in place to classify and maintain records. Interprets & enforces all documentation formatting standards policies and operating procedure requirements. May identify submission components communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data extract pertinent information prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local regional and divisional customers.Job Description
This role offers hybrid working requiring 3 days per week in person in our White City London office. Adhoc working hours to overlap the US as required.
Major accountabilities:
- Manages medium to small level global regulatory submission projects.
- Provide submission and contribute to the technical related regulatory strategy intelligence and knowledge required to develop register and maintain global products.
- Contribute to strategic and technical input /support to drive implementation of global systems tools and processes to support global development projects and/or marketed products.
- Frequent internal company and external contacts.
- Represents organization on specific projects Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt Distribution of marketing samples (where applicable)
Minimum Requirements:
Bachelors degree in life sciences or relevant discipline.
Fluency in English
Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
Experience with electronic clinical document publishing standards/formats electronic and global regulatory submission publishing standards/formats (e.g. eCTD EU CTR).
Working knowledge of publishing tools (e.g. DXC eCTD Xpress Veeva) global submission validation tools Document Management systems Toolbox HA electronic submission gateways IRIS CTIS MS Office tools
Familiarity with global Clinical and Regulatory HA requirements (e.g. FDA ICH EMA MENA region CH MHRA)
Strong interpersonal and project management skills and experience working in a complex global cross functional organization.
Highly motivated organized and detailed oriented team player
Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. to Diversity & Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here: Desired
Clinical Study Reports Data Analysis Documentation Management Lifesciences Operational Excellence Regulatory ComplianceRequired Experience:
Exec
Employment Type
Full-Time
