Job Description

My client based Northern Suburbs, Cape Town, is seeking a Regulatory Affairs Specialist to join their team.

• Under the full supervision of the Senior RA Manager, conduct due diligences on new product dossiers and variation packages prior to submission to Health Authority.
• Provide support to ensure that all regulatory submissions such as new applications, line extension and/or variations are prepared, submitted and approved in a timely manner to meet business targets covering all products in the various OSA markets.
• Collaborate closely with the local technical representatives (LTRs) of the respective country to attain quick approvals of new applications, line extension and/or variations submission.
• Provide support on lifecycle management for all existing pharmaceutical products marketing authorisations and fast-track Health Authority (HA) approval for the variations of these authorisations.
• Provide support on Regulatory Intelligence by keeping abreast of emerging Acts, legislations and guidelines pertaining to the OSA markets.
• Timeously report all regulatory changes that may potentially have business impact.
• Address HA queries and make timely follow-up on responses in accordance with the requirements as set out from the Regulatory Authorities.
• Provide support to the maintenance of licenses in OSA markets and any GMP license for the product portfolio.
• With the support of Senior RA Manager, provide launch support to ensure compliant status of products to be launched through efficient contribution to the launch process (i.e. submit change control timeously, initiate artwork timeously, notify manager of any pending changes that will affect launch).
• Ensure that no launch delays emanate from the regulatory department and mitigate launch limitations through smart variation planning.
• Provide support to regulatory team on various projects, where deemed necessary.
• Ensuring regulatory compliance for all commercialised products
• Capture and communicate regulatory submissions and approvals via internal regulatory systems (i.e. Veeva Vault system).
• Ensure timeous completion of all assigned trainings from the My Learnings portal system and participate on other internal trainings and workshops.
• Maintain proper records of all correspondence, applications, etc. relevant to product information.
• Support with the management of specific projects to ensure continued marketability of SSA products when necessary.
• Assist with other ad-hoc Regulatory specific projects e.g. labelling compliance, audit requirements, promotional material review, change control assessment, LENC projects etc.

Qualifications & Experience:

• First Degree in scientific discipline, or able to demonstrate equivalent level of knowledge.
• 1 xe2x80x93 2 years of working experience in regulatory, production, quality or medical within the pharmaceutical industry.

Preferred Qualifications & Experience:

• Communication and inter-personal skills.
• Inspire teamwork and motivate others towards a goal achievement.
• Knowledge and understanding of pharmaceutics, pharmacology, therapeutic areas, etc.
• Literacy in the following software packages: Microsoft Office - Excel, Word and other Microsoft Tools.
• Ability to work well under pressure.
• Ability to meet the deadlines for the regulatory specific projects.

Please note only shortlisted candidates will be contacted.

Manpower