Senior Regulatory Affairs Pharmacist: Pain, Derma

1 week ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time

Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD) - POS24205

Area : Midrand

Salary R950 R1m

Qualifications

  • Bachelors 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.

Key Job Outputs

  • Manage work streams for- and report on the assigned portfolio of products:
  • Internal product queries from relevant departments
  • 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
  • Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary
  • medicines and medical devices.
  • Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines
  • and other human medicines.
  • 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
  • for variations (CMC & Labelling), Renewals, Artwork updates etc.
  • 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
  • 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
  • Must demonstrate responsibility, excellence and collaboration and align with Company values

Closing Date: 25 July 2024

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