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