Careers

Regulatory Specialist and Manager

Overall Purpose of the Position: 

The main purpose of this position is to manage and lead the regulatory team, optimizing   efficiency across all clinical trial regulatory functions, encouraging and participating in regulatory and development projects in line with the strategic objectives of the company.

Key Performance Areas (KPAs) & Responsibilities include, but not limited to:

  • Coordinating and performing various regulatory duties including, but not limited to, the collection, compilation and preparation of materials for submission to regulatory and other related bodies in line with TASK SOPs, policies and guidelines
  • Following standard procedures, processes and regulations for the collection and processing of study site documents / essential documents and site information for study submissions and other continuous communication with SAHPRA and Ethics committees
  • Ensuring initial protocol, ICF and document review and writing. This includes adding the site-specific requirements where needed
  • Managing and leading the team in line with TASK values and strategic objectives
  • Ensuring compliance with ongoing reporting requirements to local regulatory authorities and ethical committees and in line with international requirements, where applicable
  • Effectively addressing and or responding to requests / enquiries from local and global regulatory agencies
  • Providing regulatory direction to all stakeholders, devising strategies where needed
  • Exercising a proactive and flexible approach to resolving any issues and mitigating risks
  • Independently communicating with regulatory and governmental agencies to build and maintain professional relationships and where necessary coordinating meetings with Regulatory and related bodies
  • Developing and/or reviewing standard operating procedures as required
  • May be required to act as a representative and collaborate on local and international projects and regulatory initiatives
  • Coordinating site start up activities, from feasibility, contracting, to site activation
  • Working with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, Finance team, Data Management team and Clinical Planning including Monitoring needs)
  • Attending team and operational team meetings and provide updates
  • Mentoring junior staff members to improve quality of outcomes and to maintain team morale

Ideal Requirements

  • Bachelor or Masters degree, or equivalent work experience, in a scientific or healthcare discipline or related field
  • Advance knowledge and experience in clinical trial regulatory functions (3+ years of previous clinical trial / regulatory / quality assurance experience) will take preference
  • Management experience
  • Excellent computer skills, including MS Office Suite
  • Valid GCP certificate / previously attended GCP
  • Presentation / facilitation experience and / or wiliness to facilitate courses at TASK
  • Project management experience would be an advantage
  • Valid Driver’s license

Key Personal Inherent Characteristics

  • Strong writing, communication, and interpersonal skills
  • Strong attention to detail, demonstrate initiative, ability to multi-task and to balance competing priorities
  • A good grasp of the business environment, industry trends and requirements
  • Capable of working independently and exercising independent judgement
  • Excellent understanding of global /regional / national country requirements/ regulatory affairs procedures for clinical trial authorisation
  • In depth knowledge of all applicable national regulatory and Research Ethics requirements
  • Strong problem solving and analytical skills
  • Expert knowledge of ICH, SA Good Clinical Practice and other global regulatory guidelines

Details:

Area: Parow, Cape Town

Contract Type: Permanent

Applications Close:  22 August 2022

Please use the following reference when applying for this position: Regulatory Specialist and Manager

 

Send applications to vacancies@task.org.za

If you have not received a response within two weeks, your application was most likely unsuccessful.

 

TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.

 

Meeting our employment equity goals will be acknowledged during the recruitment process.

By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.