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Johannesburg: Senior Regulatory Affairs Pharmacist posted by OttoBauthentic

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Job Description

MAIN PURPOSE OF JOB

  • Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

CORE KEY AREAS

  • Submission of new pharmaceutical products for registration
  • Renewals of pharmaceutical products
  • Maintenance of registrations

RESPONSIBILITIES

  • Evaluate the dossier or variation documents and complete a gap analysis
  • On receipt of additional data (if required), compile the application for submission in accordance with the requirements for such applications, prescribed by the Health Authority(HA)
  • Create a complete electronic copy of the application
  • Submit the application (with samples if required) to the HA
  • Attend to subsequent correspondence from the HA to address any requests for additional information within deadlines specified.
  • Ensure product records/databases are updated in line with good documentation practices and company requirements.
  • Review the impact of planned changes on registrations
  • Review of printed packaging for compliance with legislated requirements all affected markets
  • Review of marketing material in compliance with the marketing code and country specific regulatory requirements
  • Any other task relevant to the RA department as requested by management

QUALIFICATIONS & EXPERIENCE

  • B. Pharm Degree
  • 3-5 years experience in pharmaceutical regulatory affairs (SADC, EAC preferred)
  • Knowledge of relevant medicine legislation and guidelines
  • Ability to read regulatory authority guidelines, assimilate and interpret this data to provide accurate, succinct submissions.
  • Ability to argue scientifically where sufficient justification exists to request exemption from certain requirements stated in guidelines.
  • Ability to work independently
  • Ability to follow instructions
  • Excellent computer skills (Microsoft word, adobe, excel).
  • Ability to produce high quality documents.
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About Other Medical Jobs in Gauteng

In Gauteng, the general job market trend for Other Medical positions is typically driven by an increasing demand for healthcare services, particularly in urban areas. This growth is often attributed to a growing population and an aging demographic, leading to a surge in medical tourism and specialized care needs.

When it comes to salaries for Other Medical professionals in Gauteng, it’s essential to note that compensation can vary widely depending on factors such as experience, company size, and industry sector. Generally, salaries tend to be higher in larger organizations or those in high-demand sectors, but even within smaller companies, salaries can still be competitive. Typically, salaries range from R400 000 to R700 000 per annum, with more senior roles or those in specialized fields potentially falling outside of this range.

Common skills required for Other Medical positions in Gauteng often include a strong foundation in medical sciences, excellent communication and interpersonal skills, the ability to work effectively in a team environment, and proficiency in relevant software applications. Many professionals in this field also possess advanced degrees or certifications, which can enhance job prospects and career advancement opportunities. Additionally, the ability to remain calm under pressure, think critically, and make sound judgments is essential for success in this role.

In terms of industry sectors, Other Medical professionals are often employed in financial services, technology industries, manufacturing sectors, and healthcare organizations. These sectors frequently require specialized care or expertise, making them attractive employers for medical professionals. While specific companies may not always be publicly disclosed as major recruiters, larger multinational corporations like Google and Microsoft often have a presence in these industries.

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Career development opportunities for Other Medical professionals in Gauteng are generally excellent, with many individuals progressing to senior roles within their current organization or transitioning into leadership positions within healthcare organizations. With experience, advanced degrees, or certifications, professionals can explore specialized fields like medical research, policy development, or medical education, which offer greater autonomy and professional fulfillment.


This information provides general career guidance. Actual salaries and requirements vary by employer.



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