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Regulatory Affairs Manager

3 months ago

Midrand, South Africa Jordan HR Full time
Key Job Outputs
  • Manage work streams for- and report on the assigned group
  • Co-ordination and submission of new product applications in South Africa and other applicable territories.
  • Ensure the maintenance and/or update of existing registrations in accordance
  • with the relevant legislation, regulations and guidelines
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines
  • pertaining to the pharmaceutical industry.
  • Internal training and mentoring
  • Establish and maintain effective relationships with Regulatory Authorities,
  • internal and external stakeholders
  • Formulate or implement regulatory affairs systems, policies and procedures to
  • ensure that regulatory compliance is maintained or enhanced.
  • Manage activities such as internal audits or regulatory agency inspections
  • Ensure alignment of personal and company value

Core competencies
  • Experience in use of CTD software builder and compilation of eCTD application
  • will be an advantage.
  • IT skills
  • Leadership skills
  • management of personnel resources
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • Active learning
  • Strategic thinking
  • Ability to cope with a high degree of complexity and change
  • Cross Functional skills: Ability to network, liaise and negotiate with others
  • Ability to set standards and objectives and monitor progress
  • Complex problem solving and decision-making skills
  • Customer relationships
  • Development of people
  • Must demonstrate responsibility, excellence and collaboration and align with
  • Company values

Qualifications

  • Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Experience
  • Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines.
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards