Job Description

COMPANY DESCRIPTIONWe are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.
The Groups key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.OBJECTIVE OF ROLE
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 the region, by ensuring successful Marketing Authorisation and variation approval from the Regulatory Authorities within the committed timeframe. The role undertakes responsibility for compliance with the Regulatory requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the Regulatory plan.
Perform regulatory functions to secure Marketing Authorisation, and life-cycle management of the dossier post registration, through effective dealings with internal and external customers and regulatory authorities.
Contribute special expertise cross functionally and provide technical and procedural training to the department and junior personnel. Peer review junior personnels work and provide guidance as required.KEY RESPONSIBILITIES
Financial

• Effective utilization of resources to keep procedures cost effective

Customer

• Display a professional attitude when responding to customers
• Propose, develop and update methods to improve customer services
• Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, External consultants and Agents, Quality Assurance, Project managers, Artwork, New Product Launches, Manufacturing Sites, Pharmacovigilance, Medical Information, AGI, APTL,

Quality management

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.

Due diligence

• Perform due diligence on new IP identified for licensing/acquisition to identify deficiencies in the IP relating to SAHPRA and SADC member states laws and regulations, in compliance with timelines in licensor/purchaser agreements
• Raise all risks and critical issues with line manager at DD stage before issuing DD report
• Request CCDS/PI, frills, samples, etc. from the relevant departments as per process, within specified timelines
• Follow up with stakeholders on DD requests until finalization of outstanding matters, ensuring a quality and compliant submission.

New registration applications

• Use eCTD publisher and dedicated I-drive to compile quality dossiers which are compliant with country specific requirements, guidelines, regulations, and internal departmental procedures, within the allocated timelines, ensuring smooth progression to

Marketing Authorisation

• Raise any minor additional data requirements identified at compilation stage so as not to compromise proposed submission date
• Ensure required fee is paid to the Authority
• Ensure relevant support personnel are asked timeously to prepare the electronic or hard copy submission, over-see and review such activities
• Ensure proof of receipt from relevant Authority is received and recorded
• Update and maintain all appropriate trackers, databases and systems as required to ensure visibility and accurate reporting
• Attend to action items in electronic QMS to ensure compliance with completion/closeout timelines.

Response to screening outcomes and recommendations

• Compile and submit compliant responses to screening outcomes from regulatory authorities by requesting additional data/frills/samples
• Over-see the compilation of post-screening copies, take responsibility and sign relevant documentation after verifying quality/compliance of the response
• Over-see completion of administrative functions as per departmental procedures
• Compile and submit compliant responses to recommendations from the following Units, being aware of communicating risks to line manager:
• P&A Unit
• Inspectorate Unit
• Names & Scheduling Unit
• P&A Variations
• Marketing Authorisation Renewals
• Action and close out electronic QMS items
• Over-see completion of administrative functions as per departmental procedures

Registration

• Ensure new Marketing Authorisations are up to date with all pre-registration activities, including recommendations from all relevant Authority committees or units.
• Ensure that all labelling components are updated with the registration details as per departmental procedures
• Ensure that translated labelling text is available if required as per country specific requirements
• Ensure that accurate labelling text is provided to the Artwork Department via the Artwork Management system, for implementation in the market
• Consider impact of registration details on shared packs
• Receive and review registration certificate for errors, and arrange correction
• Check for post-registration variations and notify line manager of these as per process
• Action and close out electronic QMS items
• Over-see completion of administrative functions as per departmental procedures

Dossier maintenance (variations)

• Submit Variations to regulatory authorities in accordance with laws and regulation
• Ensure required fee is paid to the Authority
• Receive and distribute approval documentation from regulatory authorities as per departmental procedures
• Update and maintain all relevant trackers, databases and systems
• Action and close-out electronic QMS items
• Over-see completion of administrative functions as per departmental procedures

Projects

• Coordinate and manage projects as required

Training

• Provide technical and procedural training to the department in line with development needs
• Provide one on one training and coaching to less experienced staff and reviewing their work as required

EDUCATIONAL REQUIREMENTS
xc2xb7Matric/Grade 12
xc2xb7Bachelor of Pharmacy degree or equivalent.KNOWLEDGE & EXPERIENCE REQUIREMENTS
xc2xb7 Minimum 2 years experience in a Regulatory Affairs environment, including compilation and submission of new product applications and variations in accordance with the latest requirements.
xc2xb7 1-2 years experience within the pharmaceutical industry in a Production/Quality/Clinical environment a distinct advantage
xc2xb7A solid understanding of The Medicines and Related Substance Act Act 101 of 1965 and Regulations, and the Acts and Regulations of SADC member states
xc2xb7 Comprehensive knowledge of SAHPRA Guidelines, and those of SADC member states where relevant Knowledge of principles governing regulatory requirements such as ICH and WHO Technical knowledge of the CTD, eCTD and SADC member states dossier formats where applicable
xc2xb7Knowledge of project management principlesSOFT SKILLS REQUIREMENTS
xc2xb7Integrity. Good work ethic and ability to meet deadlines
xc2xb7Good interpersonal skills
xc2xb7Information seeking
xc2xb7Business analysis and financial skills
xc2xb7Problem-solving and good judgment
xc2xb7Accuracy and Attention to detail
xc2xb7Time Management
xc2xb7Resource efficiency
xc2xb7Risk management
xc2xb7Responsibility and accountability
xc2xb7Initiative
xc2xb7Results oriented
xc2xb7Systems thinking
xc2xb7Planning and organisational skills
xc2xb7Focused
xc2xb7Informal communications skills
xc2xb7Active listening skills
xc2xb7Writing skills
xc2xb7Presentation skills
xc2xb7Empathy
xc2xb7Flexibility and tolerance for ambiguity
xc2xb7Transition management
xc2xb7Capacity for and resistance to stress
xc2xb7Ability to work under pressure
xc2xb7Perseverance and tenacity
xc2xb7Technical / professional knowledge
xc2xb7Industry knowledge
xc2xb7Curiosity / learning agility
xc2xb7Self-awareness
xc2xb7High standardsCOMPUTER SKILLS REQUIRED
The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CVs online on or before 01 June 2025. Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application for this specific role.