Regulatory submissions process manager - Mechelen, BE
Galapagos
Mechelen, Belgium
6 dagen geleden

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing b iotech company with offices in Europe, in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in the US (Boston).

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before.

In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.

Collaborative innovators and perseverant idealists, we need the best-in-class. In other words, we need you : The make-it-happeners’.

We are looking for a Regulatory Submissions Process Manager.

Your role :

The regulatory submissions process manager will be responsible to establish a collaborative way of working with our partner on the development of the global submission dossier.

The global submission dossier needs to provide a global as well as regional context to ensure that both companies’ filing and regulatory compliance objectives will be met.

The regulatory submissions process manager will further be responsible for the preparation and full and flawless execution of the EU Marketing Authorisation Application submission plan.

The EU MAA submission plan will need to be developed in close collaboration with the Galapagos’ Regulatory Leader and the cross functional Project Management Leader, with input from the respective functional area topic experts.

Principal Accountabilities :

  • Core member of the Galapagos regulatory submission subteam, with a link to the PMO organisation.
  • Facilitator and co-Lead of joint submission strategy meetings with our partner.
  • Lead of submission strategy meetings at Galapagos.
  • Liaise with counterpart(s) to agree on roles and responsibilities in the global submission dossier development for an initial marketing authorization taking into account a 50 / 50 collaborative development and availability of resources.
  • Develop a granular plan for the global submission dossier and generate a derived, detailed EU MAA submission plan. The EU MAA submission plan should contain granular preparation and review timeline, focused on the critical and near critical phase, with timely identification and execution of non-critical path activities in advance of the critical phase.
  • Execute the EU MAA submission plan with relevant internal stakeholders.
  • Ensure timely identification of document owners, authors, reviewers and approvers.
  • Ensure well upfront identification of critical periods with assessment of and proposal for specific facilitation measures.
  • Implement an effective document review tool that allows collaborative work between the two companies.
  • Conduct lessons learned / document best practices post submission.
  • Identify issues and escalate as needed.
  • Who are you?

  • You have more than 7 years experience with major EMA / EU submission(s) and regulatory submission project management.
  • Thorough understanding of eCTD structure, modules and interlinks, and resource needs.
  • Project management expertise in other area’s of drug development will be an asset.
  • Thorough understanding of the drug development process.
  • You have experience in collaboration projects
  • You are an expert in using planning tools
  • You are open to travel 30% of your time
  • What’s in it for you ?

    You will be part of a fast growing and amazing company. As make-it-happener’ you will get all the support you need to make your job successful.

    At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills.

    Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research.

    Galapagos offers a competitive remuneration package and a dynamic work environment.

    We are Galapagos : together we can make it happen !

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