Senior Regulatory Affairs Pharmacist with OTC Expertise

3 weeks ago


Midrand, Gauteng, South Africa Emporium Human Capital Full time

Job Title: Senior Regulatory Affairs Pharmacist with OTC Expertise

Job Summary: We are seeking a highly skilled Senior Regulatory Affairs Pharmacist with expertise in OTC products to join our team at Emporium Human Capital.

This role involves managing work streams and reporting on assigned portfolios of products, establishing regulatory priorities, and allocating resources and workloads. You will review regulatory agency submissions and ensure compliance with regulatory standards. Additionally, you will develop regulatory strategies and implementation plans for new product applications and conduct dossier due diligence to ensure data gaps are addressed.

Key Responsibilities:

  • Manage work streams for assigned portfolios of products and report on progress to senior management
  • Establish regulatory priorities and allocate resources and workloads to meet business objectives
  • Review regulatory agency submissions and ensure compliance with regulatory standards
  • Develop regulatory strategies and implementation plans for new product applications
  • Conduct dossier due diligence to ensure data gaps are addressed and product registrations are maintained

Requirements:

  • Experience in Regulatory Affairs with a focus on OTC products and pharmaceutical industry
  • Proven ability to manage multiple work streams and prioritize tasks to meet deadlines
  • Strong analytical and problem-solving skills with attention to detail
  • Excellent communication and interpersonal skills with ability to work effectively with cross-functional teams
  • Knowledge of regulatory requirements and guidelines in the pharmaceutical industry


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