CAREERS old

Please note that:

  1. You need to meet the minimum requirements stated in the job profile for your CV to be considered
  2. Your application is kept confidential and is shared only as part of a structured recruitment process
  3. All credentials are checked and any false or inaccurate information may render you liable for damages and / or dismissal
  4. We reserve the right to change our requirements or not pursue applications at our sole discretion
  5. Should you not hear from us within six weeks of the closing date of the vacancy, please consider your application unsuccessful

Regulatory Pharmacist Cape Town

  • Job Title
  • Regulatory Pharmacist
  • Purpose of position
  • Manage the registration process for allocated therapeutic categories for new and existing products, including liaison with the relevant Health Authorities and third parties
  • Reporting to
  • Senior / Regulatory Manager

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

 

Product registration

  • Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required
  • Compile and submit all required dossier amendments
  • Identify and maintain updates on existing products based on MCC guidelines and allocated priorities
  • Interact on a regular basis with overseas affiliates, third parties and contractors on dossier related activities
  • Compile and submit all MCC recommendations within agreed and specified time limits
  • Assist with the identification of variations in neighbouring countries in line with South African dossier requirements
  • Manage and compile dossier conversions as per MCC guidelines

 

Technical / Compliance activities

  • Assist with annual product reviews
  • Assist with technical queries internally and with the guidance of line management, externally
  • Assist with pharmacovigilance activities as and when required
  • Manage and monitor the Change Control Process effectively

 

Packaging and marketing materials

  • Review and assist with approval of  printed packaging components and promotional material
  • Assist with compilation, review and approval of advertising material
  • Ensure all printed material (including web based), complies with the Marketing Code of Conduct and MCC requirements

 

Document management

  • Ensure the EDMS is current and up to date and in line with printed dossiers.

 

General

  • Perform any other duties as per changes in operational requirements of the department.
  • Perform any other duties as requested

PRE-REQUISITES

  • B. Pharm registered with the SA Pharmacy Council or relevant B Sc. degree, preferably at post-graduate level
  • 3-5 years Regulatory experience
  • Able to perform all standard registration processes under specialist guidance

TECHNICAL COMPETENCIES REQUIRED

 

  • Experience of the pharmaceutical industry, preferably generics
  • Computer literate and able to effectively use Excel and Word
  • Able to perform all aspects of registration processes

 

BEHAVIOURAL COMPETENCIES REQUIRED

  • Professional and presentable
  • Effective written and verbal communication skills
  • Highly organized and good planning skills
  • Self-discipline and effective administration skills
  • Highly accurate and has good attention to detail
  • Positive attitude
  • Self-motivated
  • Work well as part of a larger team

How to Apply

To apply for this position please send your CV to:

Chandre Andrews, Senior HR Officer

Email:  c.andrews@pharmadynamics.co.za / recruitment@pharmadynamics.co.za

 

 

The company reserves the right to adjust or modify the scope and / or level of the job based on applicant supply, operational requirements and/or prevailing market conditions

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