Regulatory Affairs Pharmacist - Head Office, Isando
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Date: 11 hours ago
City: Johannesburg, Gauteng
Contract type: Full time
Position Summary and Objective
Lead, manage, execute, and provide strategic direction as the regulatory affairs pharmacist registered with the South African Pharmacy Council with the regulatory management of South Africa downstream markets Botswana, Namibia, Mauritius, Zambia, Zimbabwe and Malawi for Company branded portfolio of products.
Future markets could be included as well if regulatory pathways become effective in Lesotho, Seychelles, and Swaziland.
Provide oversight for assigned countries for the branded Upjohn portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post-approval submissions.
Ensure regulatory input is communicated to the regional and local Commercial, Supply Chain, and Quality teams for promoted and development products and the implementation of special projects.
Ensure and supervise that regulatory documentation meets relevant regulatory requirements.
Apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported region's commercial objectives.
Ensure business continuity between Global Regulatory Strategists, Country.
Regulatory staff, and distributors supporting regulatory activities on behalf of the Company.
To ensure business continuity between Global Regulatory Strategists, Country.
Regulatory staff and distributors supporting regulatory activities on behalf of company
Primary Responsibilities:
Directly manage the South African downstream market. Requires close collaboration with regulatory personnel managing South African branded dossiers and working closely with personnel in the Sub-Saharan African region.
Apply regulatory expertise for assigned countries to prepare high-quality documentation and ensure compliance with departmental procedures.
Maintain a knowledge base of countries' requirements and regulatory environments.
To build regional relationship with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines.
Manage the performance of direct reports, (where applicable) to achieve agreed objectives and to identify and address training and development needs.
Provide input to the regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
Implement team spirit/activities in alignment with company culture and values to help retain/attract talents.
Provide input and liaise with Global Regulatory, CMC, Supply Chain,
Submissions Management, other company Country Offices, Labelling teams,
Artwork centers, Cluster/Market, and other key stakeholders to ensure filing strategies are defined and executed and Board of Health requirements are met, resulting in a submission-ready dossier. Ensure the appropriate regulatory systems and database are updated in a timely manner when changes occur.
Utilize a submission planning and forecasting tool to update timelines.
Facilitate and support all product lifecycle regulatory work, liaising with CMC,
Submissions Management, Cluster/Markets, and other key stakeholders.
Ensure and oversee the preparation of regulatory strategies and plans for assigned countries, including the review of existing regulatory guidelines and relevant literature.
Ensure adequate input to the local/regional company commercial strategic planning process as appropriate.
Advise, where necessary, with direct reports and Global Regulatory Leads the receipt, distribution, and response to regulatory queries from target countries, consistent with procedures and including liaison with Rapid Response Team members to ensure that response targets are met.
Develop detailed understanding of regulatory guidelines and technical requirements and support maintenance of regulatory requirements database and assist
Regulatory Policy with assessing the regulatory environment and identifying relevant trends.
Regularly follow up with markets and distributors, if applicable, on progress of registration submission and approval activities and ensure line management are advised of progress in regulatory filings.
Key Knowledge and Skills required:
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.
Regional Regulatory experience including knowledge of NDA, multisource product applications, biosimilar submission processes and product lifecycle management processes.
Demonstrate experience of effective delivery in a complex matrix environment.
Knowledge of regional and global regulatory environment
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
Knowledge of drug development, regulations, and guidelines
Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills
Understanding of pharmaceutical industry, clinical trials, and pharmacovigilance
Knowledge and understanding of quality systems, processes, audit, and inspections.
Ability to influence at all levels in the organization
Able to simplify complex ideas and processes
Team player
Growth focused
Analytical thinking
Change agile.
Minimum Requirements:
Bachelor’s degree in pharmacy, registered with the South African Pharmacy Council
MSc, MBA, or PhD may be an advantage.
Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience.
Experience in the registration of products and regulatory knowledge of Botswana, Namibia, Mauritius, Zambia, Zimbabwe, and Malawi market guidelines.
Between 5 - 7 Years
Lead, manage, execute, and provide strategic direction as the regulatory affairs pharmacist registered with the South African Pharmacy Council with the regulatory management of South Africa downstream markets Botswana, Namibia, Mauritius, Zambia, Zimbabwe and Malawi for Company branded portfolio of products.
Future markets could be included as well if regulatory pathways become effective in Lesotho, Seychelles, and Swaziland.
Provide oversight for assigned countries for the branded Upjohn portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post-approval submissions.
Ensure regulatory input is communicated to the regional and local Commercial, Supply Chain, and Quality teams for promoted and development products and the implementation of special projects.
Ensure and supervise that regulatory documentation meets relevant regulatory requirements.
Apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported region's commercial objectives.
Ensure business continuity between Global Regulatory Strategists, Country.
Regulatory staff, and distributors supporting regulatory activities on behalf of the Company.
To ensure business continuity between Global Regulatory Strategists, Country.
Regulatory staff and distributors supporting regulatory activities on behalf of company
Primary Responsibilities:
Directly manage the South African downstream market. Requires close collaboration with regulatory personnel managing South African branded dossiers and working closely with personnel in the Sub-Saharan African region.
Apply regulatory expertise for assigned countries to prepare high-quality documentation and ensure compliance with departmental procedures.
Maintain a knowledge base of countries' requirements and regulatory environments.
To build regional relationship with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines.
Manage the performance of direct reports, (where applicable) to achieve agreed objectives and to identify and address training and development needs.
Provide input to the regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
Implement team spirit/activities in alignment with company culture and values to help retain/attract talents.
Provide input and liaise with Global Regulatory, CMC, Supply Chain,
Submissions Management, other company Country Offices, Labelling teams,
Artwork centers, Cluster/Market, and other key stakeholders to ensure filing strategies are defined and executed and Board of Health requirements are met, resulting in a submission-ready dossier. Ensure the appropriate regulatory systems and database are updated in a timely manner when changes occur.
Utilize a submission planning and forecasting tool to update timelines.
Facilitate and support all product lifecycle regulatory work, liaising with CMC,
Submissions Management, Cluster/Markets, and other key stakeholders.
Ensure and oversee the preparation of regulatory strategies and plans for assigned countries, including the review of existing regulatory guidelines and relevant literature.
Ensure adequate input to the local/regional company commercial strategic planning process as appropriate.
Advise, where necessary, with direct reports and Global Regulatory Leads the receipt, distribution, and response to regulatory queries from target countries, consistent with procedures and including liaison with Rapid Response Team members to ensure that response targets are met.
Develop detailed understanding of regulatory guidelines and technical requirements and support maintenance of regulatory requirements database and assist
Regulatory Policy with assessing the regulatory environment and identifying relevant trends.
Regularly follow up with markets and distributors, if applicable, on progress of registration submission and approval activities and ensure line management are advised of progress in regulatory filings.
Key Knowledge and Skills required:
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.
Regional Regulatory experience including knowledge of NDA, multisource product applications, biosimilar submission processes and product lifecycle management processes.
Demonstrate experience of effective delivery in a complex matrix environment.
Knowledge of regional and global regulatory environment
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
Knowledge of drug development, regulations, and guidelines
Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills
Understanding of pharmaceutical industry, clinical trials, and pharmacovigilance
Knowledge and understanding of quality systems, processes, audit, and inspections.
Ability to influence at all levels in the organization
Able to simplify complex ideas and processes
Team player
Growth focused
Analytical thinking
Change agile.
Minimum Requirements:
Bachelor’s degree in pharmacy, registered with the South African Pharmacy Council
MSc, MBA, or PhD may be an advantage.
Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience.
Experience in the registration of products and regulatory knowledge of Botswana, Namibia, Mauritius, Zambia, Zimbabwe, and Malawi market guidelines.
Between 5 - 7 Years
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