Regulatory Affairs Specialist

1 month ago

Kimberley, Northern Cape, South Africa Unique Personnel Ltd Full time
Job Title: Regulatory Affairs Manager

At Unique Personnel Ltd, we are seeking a highly skilled Regulatory Affairs Manager to join our team.

Job Purpose:

The successful candidate will be responsible for providing superior Regulatory services to relevant departments within the company and with external partners and Principals.

Key Responsibilities:
  • Manage work streams for- and report on the assigned group of portfolios
  • Assist with internal product queries from relevant departments
  • Assist with external product queries from the SAHPRA, other MRAs and third-party stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Coordinate and submit new product applications in South Africa and other applicable territories
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products
  • Conduct dossier due diligence to ensure all data gaps are addressed
  • Prepare the registration applications for submission to the regulatory authorities
  • Work in collaboration with internal and external stakeholders to assess regulators submissions requirements
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
Requirements:
  • Bachelor's degree in Pharmacy/Diploma in Pharmacy and 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
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards
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

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