RA Pharmacist, New Products
Aspen Pharma Group
2023-08-01 JHB North
Job Ref #: 01082023LG
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 1
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 the eQMS 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 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 eQMS items
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 eQMS 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 the 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 eQMS 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
EDUCATION & EXPERIENCE:
Matric Bachelor of Pharmacy degree or Pharmacy Diploma. 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
S KILLS & ATTRIBUTES:
Integrity. 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 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 WHO Technical knowledge of the CTD, eCTD and SADC member states’ dossier formats where applicable Knowledge of project management principles Computer literate
