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Regulatory Submission Manager

Employer
Hobson Prior
Location
Brussels, Belgium
Salary
£59638.26 - £72288.80 per annum
Start date
18 Feb 2021
Closing date
15 Mar 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Hobson Prior are looking for a Regulatory Submission Manager to join a global biopharma organisation. In this role you will provide technical guidance to submission contributors and regional input regarding agency submission requirements.


Job Responsibilities:

  • You will be the main SPARK point of contact to all Practices and PSTs for a given product.
  • Being responsible for working with Global Regulatory Affairs, Patient Solutions Teams, Practices, Affiliates and Partners to ensure regional delivery or publishing, document management, tracking and planning as required.
  • Working in partnership with the SPARK team, for the definition and management of global and regional publishing strategies for their assigned product to meet all regulatory submission requirements, ensuring that dossier structure, metadata and submission archives are compliant and consistent throughout the end-to-end submissions process, enabling effective re-use between submissions.
  • Providing technical guidance to submission contributors and regional input regarding agency submission requirements.
  • Publishing planning, working with authors to ensure submission readiness of documentation for assigned submissions and acts as product dossier historian.
  • To lead or contribute to the development of global processes and standards for regulatory submissions and technology projects.

Requirements:

  • Several years of experience in the pharmaceutical industry, with specific experience related to the preparation of regulatory dossiers and use of document management systems including electronic repository platforms with emphasis in submission publishing.
  • Previous experience in the preparation of electronic submissions, including eCTD and other regional electronic formats with experience in managing eCTD lifecycles and validation.
  • Experience in preparation of documents for regulatory submissions to meet authority requirements and company standards, including extensive knowledge of Microsoft Word and Adobe Acrobat functionality.
  • Extensive knowledge of regional regulatory agency requirements for electronic submissions format and delivery including detailed knowledge of eCTD specifications and validation requirements. Some direct experience with regulatory agencies.
  • Extensive knowledge of standard industry submission technologies and best practices related to submission preparation, archiving, and tracking.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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