A Pharmaceutical Company based in Bryanston, needs to appoint a Regulatory Affairs Pharmacist with 2-3 years RA experience. Multi-National experience is required.

Key Performance Areas:
Initiate and manage the registration process for new product submissions and maintenance of existing registrations
Pro-actively Manage Regulatory Processes of Key Products (New products, line Extensions and actively promoted products)
Effectively manage allocated artwork projects in the Global labelling system.
Consolidate and strengthen Regulatory Leadership role and Market access priorities
Effectively managing, auditing and implementation of Regulatory and QA systems
Maintain a high level of Regulatory intelligence e.g. on existing and developing regulations and on the overall competitive landscape in South Africa.
Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
Prepare, review and adhere to Standard Operating Procedures (SOP’s) and local Guidelines
Maintain administrative systems
Establish and maintain customer relationships and stakeholder partnerships
Alignment of personal and company values

Minimum Requirements
B.Pharm or Dip Pharm qualification essential
Minimum 2-3 years Regulatory experience in the aspects of dossier preparation and submission
Registration with the South African Pharmacy Council
HSA/ Quad pharmaceutical registration course (Preferable)
A demonstrated ability to negotiate and communicate with key customers such as the MCC and Global Regulatory Affairs

Competencies
Computer literacy in MS Office Suite
Excellent written and verbal communication skills
Time management and planning skills
Strong interpersonal skills with a customer relationship focus
Uncompromising attention to detail and accuracy
Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
Ability to work independently in a high pressurised environment