X2 Regulatory Affairs Scientists – OTC
[Apply Now]Date Published : 23 Feb 2017 | Category: Regulatory Affairs | Expiry Date: 06 Mar 2017 | Location: Midrand | Reporting to: Regulatory Affairs Manager OTC
Required Learning:
BSc or equivalent Science degree in a relevant field.A minimum of 2 – 5 years Medicine Registration experience, in a Pharmaceutical Regulatory environment with dossier compilation experience.
Knowledge and experience of the Regulatory requirements for medical products in South Africa and Africa
Key Outputs :
To ensure timeous submission of variations and new product registrations in support of the wider OTC business objectivesCo-ordination and submission of new product applications
Co-ordination and submission of amendments for currently marketed products
Policy transfer of MCC and SAPC regulatory authority regulations to portfolio of product dossiers
Building and maintain effective working relationships with both the South Africa and India regulatory teams.
Assisting with internal product queries from other areas within the OTC business
Timeous assistance (co-ordination and submission of amendments) to the RA manager for managing regulatory risks of OTC product portfolio
Build and maintain working relationships
Core Competencies:
LeadershipBuilding and maintaining effective relationships – team, cross functional & external
Negotiating and Influencing
Results driven and proactive
Systems approach
High stress tolerance - ability to work under pressure
Problem Solving and analysis
Decision making skills
Team Player
[Apply Now]