vacature regulatory-affairs

Project Submission Manager

Derks & Derks Detachering

A temporary job where you can coordinate various operational regulatory activities at a global pharmaceutical company

Offer
  • diverse job as Regulatory Submission Specialist at a global pharmaceutical company
  • interesting because of the possibility to participate in a diversity of regulatory projects
  • temporary contract/assignment at Derks & Derks
Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in the Netherlands. For the location in South Holland we would like to meet an experienced and enthusiastic Project Submission Manager.

Position

As a Projec Submission Manager the primary purpose of this position is to coordinate various operational activities related to the collection, organization and dissemination of submissions and related regulatory information. This role is primarily focused on supporting regulatory activities in EMEA but may extend to other geographic regions as appropriate. By applying a disciplined project management mindset to tracking various tasks and regulatory requirements, this role helps provide broader visibility to changes in the global product portfolio and also serves as a central point of knowledge related to operational status and execution responsibilities.

You will define and support product change control and submission portfolio management processes across multiple products and therapeutic areas, with a focus on one of the regions EMEA, Americas, Japan or Asia. You record submission planning and execution activities in accordance to defined submission strategy for products and projects within agreed timeframes using defined procedures. Furthermore, you document and track submission activity, you ensure approvals are captured and documented, and you communicate relevant events to stakeholders. You organize and coordinate information exchange among RA functions as well as stakeholder groups such as QA, Manufacturing, Study Start-up Office or Contract Research Organizations and you assist RA staff in preparing some submission information as appropriate, such as drafting cover letters, completing electronic forms, and ensure all Health Authority interactions are documented consistently. You identify changing regulatory guidance and anticipate impact on submission preparation and processing and you will train other staff members and serve as subject matter expert on project management-related systems and processes if necessary.

Profile
  • Bachelor’s degree
  • Familiarity with applicable regulations, interpreting regulatory guidance and monitoring the external regulatory environment for changes that impact submission standards or other regulatory practices
  • Preferably industry experience 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
  • Ability to communicate effectively, establish and maintain productive working relationships, and influence peers and others within the organization
  • Familiarity with project management software, e.g. Microsoft Project
  • Familiarity with registration tracking, submission and document management systems and concepts
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple diverse projects simultaneously
  • Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/18-116-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

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