Job details

Regulatory Affairs Coordinator

Company details

Our client Aquilon Pharmaceuticals is a company active in the development of innovative drugs in the respiratory field. As the company is growing, they are currently looking for a Regulatory Affairs Coordinator.

Function

Your Mission:

The successful candidate will contribute to the development and execution of Regulatory CMC strategies, submissions and compliance activities from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD’s, MAA’s,…) to regulatory agencies.

Your responsibilities:

As Regulatory Affairs Coordinator, you will also:

  • Leads the preparation of CMC information for submission to regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans, including major, complex applications.
  • Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Interfaces directly with Boards of Health, including scientific reviewers, administrative staff,… in order to discuss and define regulatory applications
  • Acts as the CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
  • Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial product
  • Gathering all the information in order to prepare the submissions to the relevant authorities for the certification/registration according to the EU regulations.
  • Follow up the regulatory documentation, checking the EU regulations updates
  • You manage the request, submissions and storage of medicinal product samples according to procedure
  • You verify if imported medicinal product batches are conformed with the current license and take appropriate actions if not
  • Establish a stakeholders’ engagement model allowing representation roles within working committees, associations, federations, networking event, roundtables, seminars, etc. to be related to outcomes defined in the public affairs and engagement strategy

Profile

Your profile:

Hard skills:

  • 10 years of working experience in a similar position (or in a CMC Project Management)
  • University level education (Master or PhD), with a scientific background
  • Experience in the health sector, with excellent understanding of policy and regulation in pharmaceutical and/or medical devices strongly desired
  • An additional experience in formulation developments is an asset.
  • Good understanding of the product development process from formulation to registered batches manufacturing
  • Good knowledge of the regulatory requirements (i.e. GMP and additional regulatory requirements from EMA and/or FDA) allowing successful registration with the authorities.
  • Given that most of the new developments are targeted for the EU&USA, experience with EMA and/or FDA requirements is a must.
  • Excellent knowledge of English (both spoken and written); with fluency in French being an asset

Soft skills:

  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Proven track record in product management or equivalent with knowledge of product management techniques and tools.
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
  • Ability to understand and analyze scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.
  • Strategic thinking, strong problem-solving and analytical skills
  • Understanding the scientific principles and regulatory requirements
  • Communication and motivation skills
  • Ability to work in a team
  • Detailed oriented
  • Strong sense of planning and prioritization
  • Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environment

Language

  • Excellent knowledge of English (both spoken and written); with fluency in French being an asset

Offer

  • Stimulating challenges in a flexible & fast growing Start-up
  • Expert and passionate colleagues with friendly working surrounding
  • Career growth as the company grows
  • Autonomy and independence

  • Placed on:Wed 23 June 2021
  • Location: Liège

Profile Group

Avenue Blonden 40/011
4000 Liège

E-mail

Interested?

For more information:
Call OLIVIER CEYSSENS
at the number: 0479636368
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