Regulatory Affairs Pharmacist at Aspen Pharma Group

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 requirements 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 the 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 team members 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/quality environment 
• Proficiency in Afrikaans is essential.

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 November 2020. 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.