Jul 28, 2021
Reference Number: 050721 Main Purpose of the Role:
To support the South African Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of the current product portfolio in South Africa and the South African Development Community (SADC) region, by planning and implementing the Regulatory strategy to ensure successful Marketing Authorisation and variation approval by the Regulatory Authorities of the South African and SADC member states within committed timeframes.
The role undertakes responsibility for managing the Regulatory strategy and requirements for the New Product Launch Pipeline and the existing product portfolio in the South African and SADC regions, through the management and implementation of the Regulatory Plan for a defined portfolio of products
REGULATORY STRATEGY AND PLANNING
Provide input to, and project manage the South African Regulatory Plan to ensure successful, ongoing delivery and progression of commercial strategy Drive the local implementation of the Group Regulatory Strategy and SA Commercial Regulatory Strategy for the SA business Implementing short- and mid-term objectives for registration. Ensuring all plans are met on time and in Actively monitor and trend Regulatory Authority response times to provide as accurate as possible estimated registration times to the business and relevant stakeholders, for SAHPRA Backlog and BAU new products and SADC new products Ensure that risks and issues that could potentially negatively impact the Regulatory Plan, are timeously escalated to senior Provide strategic regulatory business Follow-up on outstanding approvals Provide and gather input, facilitate, co-ordinate and submit responses on behalf of Aspen regarding proposed Regulations, guidelines, and industry proposals and propose contingencies for the management of changes as a result thereof where Advise on the various regulatory requirements, both within SAHPRA / SADC Health Authorities and outside of SAHPRA which govern pharma, consumer, complementary, cosmetic and FMCG products Provide advice on the suitability and/or registrability of new products for the SA portfolio, NEW PRODUCT LAUNCHES
Manage the Regulatory interface with the respective teams in the launch process Provide regulatory information to the New Product Launch team and assist with any Formulate/propose plans and/or strategies to manage queries and requests from both internal and external customers Ensure pre-registration product submission and registration activities on time and in full Assist to drive the pre-registration process at each level (Pre-submission, post-submission, Due diligence, Health Authority review, pre-launch activities) by providing direction and guidance to ensure all regulatory milestones are achieved Ensure that all assigned dossiers are submitted timeously to the relevant Health Authorities and are followed up on a regular basis as per a predefined engagement plan and process in order to ensure shortest time to market registrations Ensure the RA: IP and Dossier Management department follows the standards, protocols and process around obtaining dossiers and gathering supporting data from suppliers following signing of supply / purchase / financial agreements Ensure there are processes for complete RA quality checks on all documents submitted to SAHPRA and SADC Health Authorities Review / Assess & approve proprietary names for new products for submission to SAHPRA Initiate, evaluate & authorise change controls for all changes to product registrations or pre-registration planning Evaluate potential new products for launch from a regulatory perspective Tracking, monitoring and follow up of responses to and from Regulatory Authorities to facilitate timeous registration in line with Aspen’s identified priorities and strategy DOSSIER MANAGEMENT
Overall management and maintenance of the complete dossier lifecycle, including compilation, submission, obtaining registration, variations, compliance and Manage the Regulatory Systems & Processes related to New Product Submissions, New Product Registrations, Life-Cycle management, and overall compliance within the department by ensuring that all processes and systems are in place to facilitate high quality, timeous submissions and responses are submitted to all Regulatory Authorities. Ensure optimal tracking of the status of all dossiers filed for Marketing Authorization, to ensure accurate, real-time reporting RA ELECTRONIC SYSTEMS
Ensure that all dossier management and maintenance activities are transferred to the Regulatory Information Management System (Veeva RIMS) in the shortest possible time Ensure on-going maintenance and clean-up of document repositories Maintain the Regulatory Affairs System (RAS) to ensure the information is current and relevant Supports the eCTD publisher system implementation and maintenance and ensures streamlined dossiers are submitted across the SA and SADC region Supports RA Lead: RA Systems with implementation and training on e-systems, as needed, and assists with the development and maintenance of e-systems Provide input, ensure compliance with current and future dossier management systems (Veeva RIM) REGULATORY INTELLIGENCE
Provide regulatory intelligence to Head of Regulatory South Africa and the Executive Team in delivering the pipeline for submissions, registrations and variation approvals Provide regulatory intelligence pertaining to the current regulatory landscape and potential impact for the team and wider business related to pipeline submission and registration for South Africa and SADC markets Provide up to date information on the different local and worldwide regulatory issues and specific regulatory requirements for the South African and SADC markets REPORTING AND TRACKING
Ensure the Dossier and the Life cycle management registration activities are tracked and reported regularly:
Attends and assists with the management of meetings within each team to ensure on time delivery of all objectives per team Ensure on time reporting and minutes are available for the Head of Regulatory South Africa Analysis and reporting of metrics for the RA: IP and Dossier Management Department to ensure relevant standards are maintained and objectives are achieved Ensure any gaps in Regulatory processes are identified and closed through cross functional discussions and solutions. Ensure on-going maintenance and enhancements on the RAS and Project Management Tool to ensure accurate real time reporting of RA KPIs. Provide accurate reporting to Executive management on predefined timelines (monthly / weekly). Ensure that comprehensive status trackers are available and maintained / kept up to date for all regulatory activities GENERAL
Supports and enables delivery for the Regulatory Affairs Department Supports the Head of Regulatory Affairs South Africa and Regulatory Affairs Department Management team to ensure that Aspen values and leadership standards are communicated and understood at all levels within the team Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating Aspen values and competencies Participates and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quo Participates in processes to share information and leverage initiatives across the department where appropriate Supports and encourages knowledge sharing between and/or across Regulatory, QA, NPL, NBD, Commercial, Project Management, SA Operations, IT, etc Evaluate the flow of projects and workload against established timelines and constantly re-evaluate activities based on changing requirements Budgets: Provide input into budgets, ensure timely preparation, and ensure budgets are adhered to, bringing any potential deviations to the attention of senior management Provides additional support in the following areas:
Ensures the department is inspection-ready at all times Supports Group with required reporting, as needed, and performs an impact assessment on changes in the regulatory landscape Ensure there is a program for RA new employee induction training Develops and manages stakeholder relationships
Identifies and develops key relationships within Aspen SA Commercial, SA Operations, AGI and Group Supports RA Management team to optimise critical relationships with the Health Authorities and Local Representatives throughout SA and SADC region Liaise with Regulatory and NPL team regarding new product submissions / resubmissions and redirect or elevate problematic / unresolved issues to the relevant people Maintain regular internal communication to advise on progress of all Submissions Cross Functional Integration support
Ensures the that the RA: IP and Dossier Management team aligns with a matrix management approach Communicates company vision and service culture Provides input and feedback around how the function can service the business optimally Engages, communicates and collaborates with the different internal business units Negotiate and communicate effectively with other Aspen offices, CRA’s and third parties. Close cooperation with work streams to support cross-functional management, including knowledge sharing. 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 Ensure that the QMS in the RA: IP and Dossier Management department is maintained and remains current at all times Set and achieve of KPI’s Prepare for, attend, and manage self-inspections, internal and external audits as Project Management:
Manage Projects as and when required, according to Good Project Management Principles Overseeing Project management activities to ensure all approved projects are integrated into the RA: IP and Dossier Management Department and are managed according to Regulator requirements and the requisite timelines for implementation STAFF AND RESOURCE MANAGEMENT
Operationalizing the human resources management and adequately implementing the available HR tools Resource needs are reviewed on an ongoing basis. Skills and performance evaluated according to company and departmental needs and policies. Allocating talent and determining position needs in terms of competencies and making the best possible use of existing competencies as a link between individual skills, knowledge and behaviour and the organization’s objectives Creating/maintaining a working atmosphere that stimulates and motivates employees by providing structured communication and information channels and initiating team- oriented activities Training and development identified and implemented within scope of company and department objectives Succession planning Talent management Lead, manage, train and mentor the RA Leads, which includes, but is not limited to the following: Managing workload for optimal performance against set KPIs and timelines Determine priorities and manage resource to ensure the Regulatory Plan is achieved Manage and review performance against set KPI’s Preparation of regular progress reports regarding assigned tasks Monitor operations to ensure compliance with regulatory requirements Facilitate regular team meetings Assess training needs, prepare, manage, and implement training programs whilst minimizing cost and downtime Coaching and Mentoring Requirements QUALIFICATION AND EXPERIENCE
Matric/ Grade 12 Bachelor of Pharmacy degree, or equivalent life sciences degree Minimum 8-10 years’ experience in a Regulatory Affairs environment, including submission and dossier management activities in accordance with the latest Regulatory requirements 5-7 years managerial experience in a Regulatory Affairs environment Experience within pharmaceutical industry in a production, quality, clinical environment would be an advantage Project management experience SKILLS AND ATTRIBUTES
Integrity, good work ethic and ability to meet deadlines 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 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 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 bothinternal and external Presentation Time Service Service Decision making Self-confidence. Organisational Logical A solutions provider Enthusiasm and drive to take ownership and drive process initiatives Occasional travel may form part of the job KNOWLEDGE
A comprehensive understanding of The Medicines and Related Substances Act 101 OF 1965 and Regulations Deep technical knowledge of the CTD and eCTD Comprehensive knowledge of SAHPRA Guidelines Knowledge of SADC Regulatory Authorities regulations and guidelines, including ZAZIBONA Computer literate Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 12 July 2021. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application.
Johannesburg, Gauteng, South Africa