Regulatory Affairs Pharmacist

1 month ago

Johannesburg South, South Africa Emporium Full time
Job Title: Regulatory Affairs Pharmacist

Emporium 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 maintaining effective relationships with regulatory authorities.

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
  • 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
  • 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
Requirements:
  • Bachelor's Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • +-5 years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities
  • 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
  • Good Manufacturing Practices (GMP)
  • Pharmaceutical production experience or exposure to supplement regulatory knowledge
Core Competencies:
  • 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

To apply for this position, please send your MS Word format CV to jobs@emporium.co.za and use POS24329 – Snr RA Pharma CC in the subject line.

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