Regulatory Operations Senior Associate

Employer
i-Pharm Consulting
Location
England, London
Salary
Negotiable
Closing date
28 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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Senior Associate Regulatory Operations

Regulatory Operations assembles the content per technical specifications and transmits to the Regulatory Agency.

Formatting and Publishing

Able to independently format, publish, transmit and archive all submission types.

Planning, publishing (eCTD), reviewing and delivery of lifecycle submissions to Health Authorities within required timelines.

Regulatory Intelligence

Advanced understanding of regulations and guidance's associated with submissions, including and most importantly in eCTD and lifecycle submissions.

Project Management and Communication

Able to answer technical questions for many submission types.

Attend Regulatory Submission team meetings, and act as the publishing SME on behalf of the Regulatory Operations function.

Technical Support

Able to answer technical questions for many submission types. Able to troubleshoot and resolve issues with critical computer application systems, e.g., MS Word, Adobe and InSight Publisher.

Skills and Requirements

  • At least 3 years of experience in Regulatory Operations, and eCTD lifecycle submissions.
  • Must be certified in InSight Publisher or be able to provide training completion certificates.
  • Proficiency in publishing eCTD submissions and using related tools, including InSight Publisher and Acrobat plug-ins such as ISI Toolbox.
  • Intermediate computer skills in MS Office, Adobe Acrobat and Liquent tools.
  • Able to multi-task and set priorities, pay close attention to details, and work in team environment.
  • Ability to collaborate with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions.

Life Sciences recruitment is what we do.

We are an award-winning international life sciences recruitment company with offices in London, New York, Munich, Singapore and Sydney.  In a highly competitive market-place, we connect top talent with the very best opportunities.

 

Our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of Contract Research & Manufacturing Organisations, Healthcare Agencies and Consultancies.

 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Contact Us
  • 212 New King’s Road
  • London
  • SW6 4NZ
  • GB
  • +44 (0) 20 3189 2299
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