Loading...

@

  • Regulatory Affairs Scientist Krugersdorp
  • MNA Recruitment in Krugersdorp, , South Africa
  • jobs
  • 4 weeks ago

jobs description

Reference: DBN003519-SS-1A leading pharmaceutical company has a vacancy for an Regulatory Affairs Scientist.
Job Purpose:

To timeously and accurately manage and compile applications for new product registration and to maintain current product dossiers to ensure legal compliance to the Medicines and Related Substances Control Act and to the legislative requirements of International Drug Regulatory Authorities.
To address any regulatory authority queries in a timeous manner.
To coordinate internal processes with Marketing, Sales and Supply Chain when necessary

Key Responsibilities:

Managing and coordinating the compilation and submission of new product applications (both local and international as per SAHPRA (South African Health Products Regulatory Authority and international Drug Regulatory Authority (DRA) requirements.
Managing and coordinating responses to the regulatory authority (clinical, ME&R, inspectorate, naming and scheduling) timeously and in accordance with authority... guidelines
Managing and coordinating the compilation and submission of dossier variation applications.
Timeous notification of business of the approvals.
Maintaining regulatory knowledge of the various territories where the registration of products is required.
Establish and maintain effective relationships with Regulatory Authorities
Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the company’s applications when required
Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
Effectively managing, auditing and implementation of Regulatory systems
Prepare, review, and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines
Ensure alignment of personal and company values

Requirements:

BSc or equivalent Science degree in a relevant field
Minimum 1-2 year’s solid experience in Regulatory Affairs, preferably in orthodox, human medicines
Demonstrable experience across the product development, commercialization, and lifecycle maintenance
Project management capabilities would be an added advantage
Proven ability to consistently deliver to quality, time and cost standards
Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
Experience in use of CTD software builder and compilation of eCTD application will be an advantage.

Competencies:

Decisiveness and Action Orientation
Drive to succeed
Teamwork
Planning & organising
Supportive orientation
Developing people
Ethical responsibility
Presentation skills
Strategic Thinking and Planning
Cross Functional Capability
Sound project management capabilities
Time management
Strict adherence to the timelines
Self-starter, able to work independently
Able to handle multiple projects simultaneously.
Good verbal and written communication skills
Sense of urgency
Perform and succeed under pressure

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.comShould you receive no feedback within 7 days, please accept your application as unsuccessful
Krugersdorp South Africa

salary-criteria

Apply - Regulatory Affairs Scientist Krugersdorp