RA Lead Variations (On-Site) at Aspen Pharma Group

PURPOSE

To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in South Africa, by ensuring successful variation approval from SAHPRA within the committed timeframe.  The role undertakes responsibility for actively coordinating, managing and implementing the Regulatory Requirements for the South African Regulatory Variation Plan

MAIN DUTIES

 PROJECT MANAGEMENT

• Provide input to, and project manage the South African Regulatory Plan to ensure successful, ongoing delivery and progression of commercial strategy throughout the product lifecycle, which involves, but is not limited to the following:
• Assist with compilations where required
• Manage the submissions to SAHPRA, including submissions portal and/or eCTD publishing
• Work closely with SA Operations sites to priorities, planning, preventing out of stock etc
• Provide guidance to SA Ops site in variation compilation and classification
• Provide guidance on motivation for changes
• Provide guidance to SA Ops sites on regulatory pathways for regulatory changes
• Updates to artwork for technical changes when required
• Any other activities assigned by the Manager
• Actively follow up with regulatory authorities where there are delays in receiving recommendations/RFI’s.  
• Actively monitor and trend Regulatory Authority response times to provide as accurate as possible estimated variation approval times to the business and stakeholders. 
• Respond to the recommendations within specified SAHPRA timelines and internal timelines.  
• Ensure optimal tracking of the status of all variation applications filed (including MAH transfers), to ensure accurate, real-time reporting using Excel spreadsheets and Project Management Tool. 
• Evaluate the flow of projects and workload against established timelines and constantly re-evaluate activities based on changing requirements.
• Negotiate and communicate effectively with other Aspen offices, regulatory authorities and third parties

QUALITY MANAGEMENT

• Ensure systems and procedures are in place in accordance with RA QMS and that these are maintained and trained according to the relevant SOP’s
• Setting and achievement of KPI’s
• Manage Trackwise/QAlign change controls, deviations and CAPA’s, ensuring timeous input and actions in order to progress the records to close-out. 
• Provide input, ensure compliance with current and future dossier management systems (Veeva RIM) 
• Prepare for, attend, and manage self-inspections, internal and external audits as required. 
• Compile weekly or monthly progress reports to provide accurate reporting to senior management. 
• Ensure that risks and issues that could potentially negatively impact the Regulatory Plan, are timeously escalated to senior management. 
• Provide input into budgets, ensure timely preparation, and ensure budgets are adhered to, bringing to the attention of senior management any potential deviations from the budget. 
• General project management.  
• Ensure that the required regulatory input is provided for artwork progression to ensure artwork compliance     with the registered product dossier. 
• Ensure that annual retention fees are paid by due dates, to maintain MA’s. 
• Ensure compliance of the registered product dossier in preparation of relaunches
• Inform relevant Aspen entities/departments of changes to regulations/legislation i.e. regulatory intelligence. 
• Close cooperation with work streams to support cross-functional management, including knowledge sharing. 
• Maintain and enhance cross-functional team relationships. 
• Lead, manage, train and mentor a team of Regulatory Affairs Pharmacists, Officers and Assistants, which includes, but is not limited to the following:

1. Allocating, coordinating, and reviewing day-to-day tasks to ensure optimal performance 
2. Managing workload for optimal performance against set KPIs and timelines 
3. Determine priorities and manage resource to ensure the Regulatory Plan is achieved 
4. Manage and review performance against set KPI’s 
5. Preparation of regular progress reports regarding assigned tasks 
6. Monitor operations to ensure compliance with regulatory requirements 
7. Facilitate regular team meetings 
8. Assess training needs, prepare, manage, and implement training programs whilst minimizing cost and downtime 

TEAM MANAGEMENT

• Create ways of doing things differently and more effectively within the department
• Challenge current ways of working with a view to suggesting more effective and efficient processes.
• Accomplish staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards
• Adhere to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by RA Manager

Requirements

SKILLS AND ATTRIBUTES

• Integrity, good work ethic and ability to meet deadline 
• Team management and leadership skills. 
• Excellent Interpersonal skills, including interpersonal and cultural sensitivity, listening and empathy 
• Conflict resolution 
• Positive Attitude 
• Strategic planning. 
• Effective organisation skills and ability to prioritize. 
• Manage evolving deadlines effectively with regular feedback and updates. 
• Understanding of the needs and priorities of the customer; Customer focused 
• Information seeking 
• Use of effective questioning to establish and understand requests. 
• Self-starter. 
• Problem solving skills. 
• Accuracy and attention to detail. 
• Ability to work under pressure  
• Ability to work in a fast-paced international environment 
• Ability to manage projects in a matrixed team environment and with both internal and external partners.
• Presentation skills. 
• Time management. 
• Service orientation. 
• Decision making skills. 
• Self-confidence. 
• Organisational awareness. 
• Logical thinking. 
• A solutions provider  
• Enthusiasm and drive to take ownership and drive process initiatives
• Occasional travel may form part of the job 

KNOWLEDGE

• A solid understanding of The Medicines and Related Substances Act 101 OF 1965 and Regulations (South Africa) 
• Deep technical knowledge of the CTD 
• Comprehensive knowledge of SAHPRA and SADC Guidelines 
• Computer literate 

EDUCATION & EXPERIENCE: 

• Matric
• Bachelor of Pharmacy degree, or equivalent life sciences degree 
• Minimum 6-8 years’ experience in a Regulatory Affairs environment, including submission and management of new product     
• applications, and variations in accordance with the latest requirements.
• 2-3 years’ managerial experience in a Regulatory Affairs environment 
• Management or Supervisory experience preferred 
• Experience within pharmaceutical industry in a production, quality, clinical environment would be an advantage 
• Project management experience.

Closing Date: 11th, July 2022