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Open nowFirst seen 5 days ago

Regulatory Affairs Portfolio Lead

Boardroom Appointments3,354 open roles

Where
Midrand, South Africa
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Your applicationOpen nowRegulatory Affairs Portfolio LeadBoardroom Appointments · Midrand, South Africa

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  4. CV RocketApplied on Boardroom Appointments's own form.

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Job Purpose:

Support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory compliance with the relevant medicine Regulatory Authorities (country-specific where applicable), Medicines and Related Substances Control Act, and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Job Outputs:

  • Manage work streams for, and report on the assigned portfolio of products:- Assisting with internal product queries from relevant departments - Assisting with external product queries from the SAHPRA, other MRA's 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 - Artwork reviews and approvals
  • 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 - 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 the regulator's submission requirements
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
  • Internal training and mentoring
  • 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, including reporting and metrics management.
  • Support activities such as internal audits or regulatory agency inspections
  • Ensure alignment of personal and company values.

Qualifications/Experience:

  • Bachelor's degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • 3 years' experience in Regulatory Affairs, preferably in human medicines with experience across product development, commercialisation and maintenance lifecycle
  • Demonstrable experience in quality-driven processes such as risk management, change control, deviations, CAPAs, Root cause investigations
  • Additional experience in African territories is preferable
  • Sound project management capabilities, with an understanding of the medicines value chain
  • Proven ability to consistently deliver to quality, time and cost standards

Core competencies:

  • Experience in the use of CTD software builder and compilation of eCTD applications.
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • 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

Should you not be contacted within 2 weeks, please take your application as unsuccessful.

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