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Regulatory Affairs Manager

Job description

We are currently looking for a RA Manager. The successful candidate will be responsible for execution of regulatory applications of various types of pharmaceutical applications.

JOB DESCRIPTION

As RA Manager, you will:

  •  Provide regulatory operations support in a start-up environment
  •  Manage regulatory submissions across different stages of the development path
  •  Manage and publish medicinal product dossiers
  •  Collaborate with vendors to submit applications and reports to applicable regulatory

agencies within established timelines and high-quality standards

  •  Keep track of regulatory procedures and organize responses to information requests and

commitments given to health authorities

  •  Manage and publish medicinal product dossiers
  • Focus on development of reformulated or repurposed value-added medicines in a broad

variety of therapeutic areas

  •  Participate in technical discussions, project meetings and reviews
  •  Collaborate with the company’s multidisciplinary team and outside partners
  •  Publish and author submission packages (including, but not limited to, Scientific Advice, CTA, MAA)

YOUR PROFESSIONAL PROFILE

  • Minimum Qualification: Master medical, pharmaceutical or life sciences
  •  Minimum Experience: 3+ years industrial experience in regulatory affairs
  •  Languages: English (written and verbal) – French is an asset
  •  Computer proficiency is mandatory
  • Experience with European & FDA regulations & guidelines on drug development is required
  •  Direct experience with publishing of submission packages is required
  •  Familiarity with GMP, GLP, GCP, and ICH guidelines is required
  •  Experience with regulatory submissions software an asset

YOUR ABILITIES

  • Demonstrates strong work ethics, and effective written and verbal communication skills
  • Strong problem-solving skills with an aptitude for providing solutions
  • Ability to balance a sense of urgency with adherence to quality
  • Excellent written and verbal communication
  • Meticulous attention to detail regarding publishing of submission packages
  • Be proactive and results-oriented with a focus on business needs
  • Strong interpersonal skills, a collaborative and trust enabling working style, building
  • partnerships among key stakeholders
  • Organizational aptitude to be a part of an outstanding team
  • Adaptability, flexibility, independence, and resourcefulness to both lead a big vision strategy
  • while also being willing to roll-up-sleeves and multi-task to thrive in a start-up environment
  • dedicated to growth
  • To have essential professional attributes include analytical thinking, team-player attitude,
  • mutual respect and understanding for cultural differences in a global team and environment and efficient utilization of time and resources

Contract

Executive search

Experience

Minimum 3 years

Education

Higher Scientific Degree

Languages

English

Sector

Pharmaceutical industry

Region

Liège

Job Type

Full-time

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