Job Openings at Aspen Pharma Group

ROLE PURPOSE:

• To perform all regulatory functions related to product quality, safety and efficacy, to update and resubmit previously submitted variations to SAHPRA according to current SAHPRA requirements. To ensure comprehensive and quality submissions to SAHPRA in order to facilitate the shortest possible approval time. To perform these functions under supervision of senior personnel, ensuring that work has been reviewed where required in order to deliver compliant, quality submissions.

SPECIFIC OUTCOMES / ACCOUNTABILITY:

UPDATE AND RESUBMIT VARIATIONS TO SAHPRA

• Updating and compiling previously submitted variations to SAHPRA according to current requirements and guidelines as per departmental procedures, within specified timelines
• Sending requests for dossier information to the relevant departments as required and as per process, within specified timelines
• Evaluating the previously submitted variations against current SAHPRA guidelines and regulations, and as per departmental procedures, within specified timelines
• Obtaining any information that is outstanding in order to complete the variation submission
• Timeously requesting, overseeing and reviewing preparation of electronic or hard copy submissions from/by the relevant support personnel
• Taking responsibility, checking and ensuring quality of the entire submission prior to dispatch/submission
• Following up and ensuring that proof of submission is obtained and saved/distributed according to departmental procedures
• Completing the required administrative functions as per departmental procedures

DEFICIENCY RESPONSES FOR SAHPRA RESUBMITTED VARIATIONS

• Compiling and submitting responses for deficiencies received from SAHPRA for resubmitted variations within specified timelines. Ensuring compliance with SAHPRA requirements, current guidelines and regulations, and as per departmental procedures.
• Reviewing the deficiency letter and forwarding requests for information to the relevant departments within allocated timelines, ensuring that the request is comprehensive and easily understandable to obtain the correct information first time
• Identifying any risks and communicating this to the line manager immediately
• Follow up with the relevant departments to ensure that outstanding data is received in good time
• Timeously requesting, overseeing and reviewing preparation of electronic or hard copy submissions from/by the relevant support personnel
• Taking responsibility, checking and ensuring quality of the entire submission prior to dispatch/submission
• Following up and ensuring that proof of submission is obtained and saved/distributed according to departmental procedures
• Completing the required administrative functions as per departmental procedures

GENERAL

• Administrative support within the department is available to the pharmacists, but the responsibility for quality of the final submission to the regulatory authority remains the responsibility of the pharmacist
• Maintaining electronic folder structure as per departmental procedures
• Complying with regulations, guidelines, policies and procedures
• Adhering to deadlines/due dates
• Timeously escalating to the line manager where possible delays are identified which could impact the due date
• Liaising with relevant internal and external customers to obtain or supply relevant regulatory information or documentation

Requirements

EDUCATION:

• Bachelor of Pharmacy degree or equivalent.
• Regulatory Affairs training and certification a distinct advantage

EXPERIENCE:

• Experience within the pharmaceutical industry in a Regulatory Affairs/Production/Quality/Clinical environment is preferable

ASPEN COMPETENCIES

SKILLS & ATTRIBUTES:

BUSINESS:

Makes Good Decisions

• Information seeking
• Responsibility and accountability

Performance Driven

• Planning and organisational skills
• Focused

PEOPLE:

Communicates effectively

• Active listening skills
• Writing skills 

Dealing with ambiguity and embracing change

• Capacity for and resistance to stress
• Perseverance and tenacity

 SELF:

Contributes Special Expertise

• Technical / professional knowledge
• Industry knowledge

Continuously grows and develops

• Curiosity / learning agility
• High standards

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MAIN DUTIES

ADVERTISING AND PROMOTIONAL MATERIAL

• Review and approve all promotional material and training material relating to the advertising and promotion of medicines and related products for the SA and SADC markets in compliance with legislation, the SA Code of Marketing Practice and any other applicable regulations/guidelines and corporate requireme This includes products marketed by Aspen on behalf of other companies or licensors
• Liaise with marketing divisions and third parties where necessary regarding advice, queries, and timelines with regard to the above
• Liaise with the Group Pharmaceutical Affairs Medical Information team regarding appropriate promotional claims, clinical reviews etc. where necessary
• Assist with the review of information relevant to each product
• Attend promotional campaign concept presentations by the brand managers and/or advertising agencies to provide regulatory support and input to the marketing teams at their request

PRINTED PACKAGING / ARTWORK

• Review and approve concept of new or updated artwork/printed packaging material for medicines and related products for the SA and SADC markets in compliance with applicable legislation and corporate requirements
• Undertake the Afrikaans translation and / or validation of Professional Information and Patient Information Leaflets for the SA market for new products and for existing products requiring updates to their safety information

MEDICINE REGISTRATION/PRODUCT LAUNCHES

• Assist with the sourcing of information and compilation of documentation required for new product launches, line extensions, marketing authorisation transfers, tender applications and the like, such as Product Launch Briefs.
• Liaise with Group Pharmaceutical Affairs and the New Product Launch team for information related to the completion of these documents where necessary

PROJECT MANAGEMENT

• Assist with the management of specific projects to ensure the continued marketability of SA and SADC products when necessary
• Provide any other support required for the continued commercialisation of products in SA and other SADC countries
• Participate in internal audits of the RA-SA team and of other internal Regulatory/QA teams in accordance with the Self-Inspection schedule
• Manage any other specific projects as and when required

GENERAL

• Liaise on a daily basis with and support the needs of all RA customers both internal and external
• Assist the RA department in implementing the plan for the SA division according to the Regulatory Strategy
• Support the Head of RA-SA and other pharmacists in their absence
• Keep abreast of changes to all relevant legislation and attend meetings and workshops relevant to the industry

SKILLS & ATTRIBUTES:

Attention to detail; Written and Verbal Communication skills; Problem solving; Analytical skills; Planning skills; Time management; Service orientation; Interpersonal skills; Initiative; Confidentiality; Customer focused; Interpersonal sensitivity; Patience; Logical thinking; Information seeking; Sense of urgency.

EDUCATION & EXPERIENCE:

• Matric
• Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council or the equivalent thereof
• Regulatory training would be an advantage
• At least 1 year of experience in the pharmaceutical industry in a regulatory affairs / medical affairs/ production / quality environment would be preferable
• Proficiency in Afrikaans is essential .

Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 25 March 2020.  Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has been 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