Regulatory Affairs Specialist - 015/2018
Code/Reference:
015/2018
Applications accepted until:
2018-05-25
Number of Openings
1

Department

Regulatory and Clinical Affairs

Employment Type

Full time

Minimum Requirements

  • Bachelor€™s Degree in Pharmaceutical Sciences or related Science discipline
  • e-CTD dossier format training and submissions
  • At least 6 years in the pharmaceutical regulatory environment.
  • Regulatory experience with preparation, submission and maintenance of dossiers.
  • National and international new drug application submissions
  • Understanding of a pharmaceutical quality system, cGMP principles and pharmaceutical legal requirements.
  • General supervisory experience.
  • MS Office proficiency (Word, Excel, PowerPoint, Outlook)

Additional Requirements

n/a

Specific Operational Requirements

  • May be required to work additional hours where critical submission deadlines need to be met.
  • The successful candidate may be required to travel and work overtime to meet the business needs.

Key Performance Areas

  • National NBI product registrations and regulatory submissions.
  • International NBI product registrations and regulatory submissions.
  • Regulatory guidance with respect to product licensing conditions, standards and compliance.
  • Trace-ability of regulatory documents and decisions.
  • Internal and external networking and support.
  • Performance management of staff.

Competencies

  • Technical / Professional knowledge and skills
  • Planning and organising
  • Attention to detail
  • Verbal and Written Communication
  • Analytical / problem solving skills
  • Work standards
  • Initiative and self-motivation
  • Self €“management
  • Networking & Liaison
  • Interpersonal skills
  • Teamwork & Collaboration