Regulatory Submission Manager

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Municipality
Leiden
Education
HBO
Hours per week
40 hours
Contract type
Tijdelijk met uitzicht op vast
Salary indication
€3000-5000
Vacancy number
#1AV0022467

About the job

About the job

Your job as a Regulatory Submission Manager
The Submission Manager is responsible for the coordination of the collection, organization and dissemination of submissions and related regulatory information. This role provides broader visibility to changes in the regional or in some cases global product portfolio and is the central point of knowledge related to operational status and execution responsibilities. You identify changing regulatory guidance and anticipate impact on submission preparation and processing other information management activities. While managing multiple projects you accurately document change and ensure all approval requirements are met before releasing product quality, patient safety, and in some cases, product sales.

As a Submission Manager your focus is on the EMEA region but you will liaise with global colleagues, senior management and global and regional Project Teams. You address complex and diverse informatics challenges with decision-making that impacts multiple projects, functional areas and therapeutic areas. Within the company you are the person whom others can ask about submission plans and other operational aspects of a product or product portfolio.

What we offer

We offer:
Name primary and secondary salary benefits + career opportunities. Adjust these based on the target group, or use general benefits.

  • A challenging and diversified job (example: in an international setting, or in a team of professionals)
  • Good career opportunities (if applicable)
  • Inspiring (dynamic) work climate (example: within a high tech manufacturing plant)
  • Attractive remuneration, which includes:
  • a 13th month
  • excellent pension policy
  • health insurance compensation
  • collective health insurance
  • company own saving scheme arrangement
  • 25 Holidays + 13 so called ADV Days
  • and more….
  • Full time job (40 hours)
  • Good salary (3000 - 5000)
  • One Year contract

Job requirements

Your personal qualifications as a Submission Manager

  • Bachelor’s degree (scientific discipline preferred)
  • Familiarity with one or more key regional Health Authority regulations, interpreting regulatory guidance and monitoring the external regulatory environment for changes that impact submission standards or other regulatory practices
  • Experience with eCTD, NEES and other technical submission formats
  • Experience with one or more European procedure types, e.g. CP, MRP/DCP
  • Experience with lifecycle maintenance, submission management and document management concepts
  • At least 3 years of previous industry experience; 2 in Regulatory Operations or in a role closely associated with interpretation of health authority regulations, product change control, labeling, submission publishing/dispatch, or registration tracking

You are a disciplined project manager and are able to track various tasks and regulatory requirements. Success will be measured in large part by the timeliness and accuracy of maintenance submissions to multiple health authorities within the EMEA. The role expects proactive collaboration and effective communication. As a Submission Manager you have strong organizational skills, a high level of attention to detail and you are able to manage multiple diverse projects simultaneously.

About the company

The company is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products.
The company employs around 950 persons in the Netherlands.

The company is based in Leiden. It's easy to reach with the car and they have free parking. Also you can go with the public transport from Leiden, Den Haag, Rotterdam and Amsterdam (Schiphol).

Job information

Unique Uitzendbureau Leiden

Schipholweg 55
2316 ZL Leiden

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