Regulatory Affairs Specialist

4 weeks ago


Midrand, Gauteng, South Africa Emporium Human Capital Full time
Job Title: Regulatory Affairs Pharmacist

Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality and safety of our pharmaceutical products.

Key Responsibilities:
  • Manage work streams for- and report on the assigned portfolio of products
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Co-ordinate and submission of 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
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
  • Update and maintain databases, trackers and systems for all regulatory related activities
  • Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
  • Internal training and mentoring of peers when required
  • 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
  • Support activities such as internal audits or regulatory agency inspections
  • Ensure alignment of personal and company values
Requirements:
  • Experience in use of CTD software builder and compilation of eCTD dossier applications
  • IT skills including Microsoft Office
  • 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

We offer a competitive salary and a dynamic work environment. If you are a motivated and experienced Regulatory Affairs Pharmacist looking for a new challenge, please submit your application.



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