Regulatory Affairs Specialist - 015/2018
Applications accepted until:
Number of Openings
Employment TypeFull time
DepartmentRegulatory and Clinical Affairs
- Bachelors 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)
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.
- 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