Applications are invited for the above vacancy that exists in the Regulatory Affairs Division. The incumbent will report to the RA Lead.
Job Description
OBJECTIVE:
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 personnel’s work and provide guidance as required.
MAIN DUTIES
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 SOP’s.
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 Veeva RIM 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 Trackwise 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 Trackwise 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 Pulse 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 Trackwise 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 Trackwise 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
Job Requirements
SKILLS & ATTRIBUTES:
Good work ethic and ability to meet deadlines
Good interpersonal skills
Information seeking
Business analysis and financial skills
Problem-solving and good judgment
Accuracy and Attention to detail
Time Management
Resource efficiency
Risk management
Responsibility and accountability
Initiative
Results oriented
Systems thinking
Planning and organisational skills
Focused
Informal communications skills
Active listening skills
Writing skills
Presentation skills
Empathy
Flexibility and tolerance for ambiguity
Transition management
Capacity for and resistance to stress
Ability to work under pressure
Perseverance and tenacity
Technical / professional knowledge
Industry knowledge
Curiosity / learning agility
Self-awareness
High standards
Knowledge:
A solid understanding of The Medicines and Related Substance Act Act 101 of 1965 and Regulations, and the Acts and Regulations of SADC member states
Comprehensive knowledge of SAHPRA Guidelines, and those of SADC member states’ where relevant Knowledge of principles governing regulatory requirements such as ICH and WHOTechnical knowledge of the CTD, eCTD and SADC member states’ dossier formats where applicable
Knowledge of project management principles
Computer literate
EDUCATION & EXPERIENCE:
Matric
Bachelor of Pharmacy degree or equivalent.
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.
1-2 years’ experience within the Pharmaceutical industry in a Production/Quality/Clinical environment a distinct advantage
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 16 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.
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