* BPharm/BSc and 2 years pharmaceutical industry experience. At least 1-2 years regulatory experience with preparation and submission of dossiers (preferably CTD format)*

Location: Pinetown, KZN

Description: A company in biotechnology and pharmaceutical industry requires a Regulatory Affairs Specialist to join their team. Key duties will include: national and international product registrations; regulatory guidance with regards to licensing conditions; traceability of regulatory documents and decisions; relationship building (internal and external); backup for Manager: Regulatory Affairs. Note that the successful applicant may be required to work additional hours where critical submission deadlines need to be met and some travel to Johannesburg will be required.
Key Requirements: BPharm or BSc in an appropriate discipline (e.g. chemistry); 2 years’ Pharmaceutical Industry experience and at least 1-2 years’ Regulatory experience with preparation and submission of dossiers (CTD format preferable); knowledge and understanding of cGMP and pharmaceutical legal requirements essential; proficiency in MS Office and related applications; clinical trial experience would be an advantage.

Additional Requirements: Analytical/problem solving skills; Attention to detail; Communication (written and verbal); High quality standard; Technical/Professional knowledge; Networking; Initiative/self-motivation.

Remuneration: Market related

Starting date: As soon as possible

*Only candidates that meet all the requirements should apply
**Please quote “Regulatory Affairs Specialist (K185)” in the subject line
***Only candidates that are shortlisted will be contacted