Regional Submission Manager

Regional Submission Manager
  • £60,000 - £65,000 per Annum
    ANNUM
  • Permanent
  • Berkshire, England, UK Berkshire UK SL6 4UB
Job Ref: J35704
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 11 March 2020
Permanent role within a global pharmaceutical company based in Berkshire available - focusing on Regulatory Submissions.

SRG are currently looking for a Regional Submission Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team to be based at their offices in Berkshire. This is a permanent role.

The Role:

As the Regional Submission Manager you will work with Submission Management, Area & Affiliate, and publishers in the creation of compliant regulatory submissions.

Objectives:

  • To manage and lead a team of Publishers and Regional Submission Specialists based in Maidenhead.
  • To also be an individual contributor in the creation and distribution of compliant regulatory submissions.
  • To support and deputise for the Head of Submission Operations as needed.

Key Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:

  • Manage a team of Publishers and Regional Submission Specialists on-site, providing direction, motivation and guidance to the team
  • Evaluate performance of and assist in career development planning for the team
  • Mentor and train less-experienced staff within the team
  • Drive team culture following the company way
  • Be the principal contact for the Affiliates for all countries accepting submissions in eCTD format
  • Manage country-specific module 1 submission planners
  • Liaise with Area & Affiliate staff to ensure Module 1 documents are identified in submission planner
  • Work collaboratively with Submission Manager to identify Module 1 documents that require Submission Management support for tracking and follow up
  • Ensure Module 1 authors know what their deliverable is and when it is due and ensure they deliver per the timeline
  • Facilitate document exchange for translation
  • Check Module 1 documents for submission-readiness and format as needed
  • Import Module 1 documents into document repository and route for approval
  • Coordinate with labelling staff in the region to ensure timely import of labelling documents into global labelling system
  • Perform QC of published paper and electronic submissions and maintain required supporting documentation (e.g. email, planners, QC documentation)
  • Produce CDs/DVDs for submission dispatch
  • Archive submissions in electronic repository
  • Perform Registration Management activities, as necessary
  • Expedite and coordinate a multitude of interrelated activities for a submission team, including Module 1 planners, in the development of published submissions within the required timelines.
  • Represent Submission Publishing on submission teams as necessary elevating timeline issues to Submission Management or Functional Manager.
  • Track metrics associated with submission planning and publishing
  • Maintain submission planner template(s) for Module 1 info
  • Plan and conduct cross-functional meetings
  • Assist in Quality Systems/SOP development and review
  • Determine and communicate submission format requirements to submission teams
  • Participate in risk-benefit analysis for regulatory compliance for submission format
  • Deputise for the Head of Submission Operations as required

Skills/Experience Required:

Regulatory Knowledge

  • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Regulatory agency structure, processes and key personnel
  • Principles and requirements of applicable product laws
  • Submission/registration types and requirements
  • GxPs (GCPs, GLPs, GMPs)
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process

Communication Skills

  • Communicate effectively verbally and in writing
  • Communicate with diverse audiences and personnel
  • Work with cross-functional teams
  • Work with people from various disciplines and cultures
  • Multilingual preferred but not required

Cognitive Skills

  • Pay strong attention to detail
  • Manage projects
  • Create project plans and timelines
  • Think analytically and critically
  • Organize and track complex information
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Has a sound knowledge of a variety of alternatives and their impact on the business
  • Apply business and regulatory ethical standards

Technical Skills

  • Technically savvy. Thorough understanding of Microsoft Office suite (MS Word, MS Excel, MS PowerPoint, MS Outlook, MS Project).
  • Must be able to demonstrate leadership skills & have lead a team before.

Education

  • Bachelor's degree (or equivalent)

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673

SRGTalent
10/04/2020 16:06:24
GBP 60000.00 60000.00
Contact Consultant:
Natasha Rollason

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