Regulatory Affairs Manager

Johannesburg, Gauteng, South Africa
PSM Personnel
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Job Description


Regulatory Affairs Manager Pharmacist ~ Regulatory
Johannesburg North-Gauteng

Our client, a pharmaceutical company, is seeking an RA Manager who will be responsible for ensuring the timely processing of regulatory applications, complying with medicine regulatory authorities, the SA Pharmacy Council, and the Medicines and Related Substances Control Act.

Qualifications and Experience

  • Bachelors degree in Pharmacy/Diploma in Pharmacy
  • Registration with the South African Pharmacy Council
  • Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Experience using CTD software builder and compilation of eCTD applications will be an advantage
As part of your role, you will be responsible for managing work streams and reporting on a group of portfolios. Your duties will include coordinating and submitting new product applications in South Africa and other applicable territories, as well as ensuring that existing registrations are up-to-date and comply with relevant legislation, regulations, and guidelines. You will also need to maintain current knowledge of the regulatory landscape of the pharmaceutical industry and provide internal training and mentoring to relevant stakeholders. Building effective relationships with regulatory authorities, both internal and external stakeholders, will be a key part of your role. You may also be required to formulate or implement regulatory affairs systems, policies, and procedures to ensure that regulatory compliance is maintained or enhanced and manage activities such as internal audits or regulatory agency inspections.

Core Competencies
  • Management of personnel resources
  • Systems and operations analysis
  • Cost management skills
  • Ability to set standards and objectives and monitor progress
  • Customer relationships
  • Development of people
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Job Detail

  • Job Id
    JD1274987
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Johannesburg, Gauteng, South Africa
  • Education
    Not mentioned
 
 
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