MSD Specialist - Regulatory Affairs Pharmacist 

South Africa, Gauteng 

538346465

Job Description

This role is responsible for compilation of registration documents for products to be submitted to the Registrar of Medicines (Act 101/1965) and Registrar of Act 36/1947 as well as export regulatory authorities. To assist with and attend inspections from the Departments of Health and Agriculture as well as export regulatory authorities. To effect an efficient and smooth running registration process with minimal return queries/resolutions from the regulatory authorities, and quick new registration time span. To compile any other documentation related to regulatory affairs. To maintain the dossier room in an organised manner and to ensure that all regulatory documents are filed in a systematic way.

ROLES AND RESPONSIBILITIES

• Study dossiers from the parent company in EU and US, and non-standardised formats, prior to compiling registration documents for submission to the respective S.A. and foreign regulatory authorities. This includes new as well as the “old medicine” (i.e. with application numbers) products.

• Compile (typing, photocopying and binding) and submit the completed documents to the various regulatory authorities (South African and Foreign authorities)

• Attend/reply to resolutions and objections from the various regulatory authorities in a timeous manner.

• Submission of, or the deletions of claims made on package inserts and labels.

• Attend meetings and seminars with reference to regulatory affairs for continuous education purposes.

• Attend meetings at the offices of the respective Registrars.

• Assist with and attend the inspections from the Departments of Health and/or Agriculture.

• Preparation and compilation of the S.O.P.’s, and Master documentation.

• Submission of renewal documents to the various regulatory authorities when required.

• Act as regulatory marketing advisor, and attend to the approval of all advertising and promotional material developed for local use as well use in any other country in which Intervet South Africa is responsible for product registrations and assist with the submission thereof to the regulatory authorities.

• Perform all packaging text approval in accordance with regulatory requirements.

• Researching information out of dossiers or reference books.

• Maintaining the storage and archiving of dossiers and correspondence in an organised and systematic manner so as to ensure safekeeping of dossiers but allowing for easy access and retrieval of information.

• Ensure timeous replies to all correspondence, local and international.

• To handle all departmental queries, telephonic and other, in a professional and helpful manner and as quickly and efficiently as possible.

• Follow up with the regulatory authorities on any outstanding regulatory issues to ensure as speedy a registration process as possible.

• Apply for all necessary permits as required by law4 and ensure timeous approval thereof. Assist with the renewal of the master veterinary import permit when required.

• Ensure proper maintenance of the electronics Regulatory Affairs Database (e.g. package inserts, application forms, letters, etc.) so that the information on the system reflects the information found as a hardcopy.

• To perform any other tasks required to ensure all aspects of the purpose statement are fulfilled.

KNOWLEDGE AND EXPERIENCE REQUIRED

• Registered pharmacistwith minimum 1 years' experience in Medicines Registrations . Veterinary medicine experience is an advantage.

• Computer literate.

• Fluent in both English and Afrikaans.

• Incredible attention to detail.

SKILLS & ATTRIBUTES

• Good planning and organising skills

• Very Analytical

• Effective Communication

• Tolerance to stress

• Technical/professional knowledge

• Energy

• Service orientation

• Highly motivated

• Adaptable

• High job standards

• Initiative

• Able to work under pressure

• Great attention to detail

• Efficient

• Reliability

• Trustworthy

• Eagerness to learn and grow within the company

Current Contingent Workers apply

Not Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:07/05/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.