Specialist RA Pharmacist at Aspen Medical

About the Job
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,

Liaise as necessary with:

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 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 SAHPRA 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 SAHPRA
• 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 SAHPRA 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 SAHPRA 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
• 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 committees/ 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

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
• Perform peer review of New Product and Variation submissions compiled by RA Pharmacists, RA Officers and operational and strategic partners
• Provide technical expertise and guidance to operational and strategic partners (internal and external) in relation to on regulatory requirements, quality and processes for New Product and Variation / RFI submissions.

GENERAL

• Participate in cross-functional activities related to Regulatory requirements, quality and process and represent RA on project teams
• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the RA function while upholding Aspen core values
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by line manager / HOD
• Active collaboration with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions
• Active collaboration with the Regional and Global teams, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
• Ensure compliance with all GxP as well as compliance with applicable local regulations.
• Keep abreast of developments in best practice and all RA, PV, MI, QA and related activities
• Maintain a high and up-to-date level of RA, PV, MI, QA and related areas of knowledge by attending conference, training courses, reading relevant medical and scientific literature.

Requirements

KNOWLEDGE

• A solid understanding of The Medicines and Related Substance Act 101 of 1965 and Regulations
• Comprehensive knowledge of SAHPRA Guidelines
• Knowledge of principles governing regulatory requirements such as ICH and WHO Technical knowledge of the CTD, eCTD
• Knowledge of project management principles
• Computer literate

SKILLS AND 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

EDUCATION & EXPERIENCE:

• Bachelor of Pharmacy degree or equivalent
• Minimum 5 years’ experience in a Regulatory Affairs environment, including compilation and submission of new product applications in accordance with the latest requirements.
• Proven ability to do thorough peer review of New Product, RFI and Variation submissions, mentor junior staff and provide technical expertise and guidance.
• More than 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 23 April 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.