Job Description
MAIN PURPOSE OF JOB
- Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries
RESPONSIBILITIES
- Responsible for new product applications.
- Compilation and submission of Post Registration amendments to ensure dossier compliance.
- Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
- Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation
- To ensure approval and compliance of printed packaging material and promotional marketing material.
- Liaising with marketing department to facilitate timeous launch of products.
- Approval of master batch documentation prior to product production.
- Responsible for SOP implementation/review, update and compliance.
- Managing and maintaining regulatory documentation filing system.
- Ensuring regulatory compliance and quality related records are available and retained.
- Ensure on-going regulatory compliance of the existing product portfolio.
- Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
- Liaise with business development for regulatory requirements prior to dossier acquisition.
QUALIFICATIONS & EXPERIENCE
- B. Pharm Degree
- Minimum 2 years experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan
SKILLS/PHYSICAL COMPETENCIES
- Docubridge
- Sage
- Smartsheet
- Sweet process
- Microsoft: Excel, Word, PowerPoint, Outlook
BEHAVIOURAL QUALITIES
- Takes ownership.
- Integrity, bound to principles, confidentiality, and ethics.
- Strong leadership skills.
- Good communication skills.
- Good organisational skills.
- Good planning skills.
- Good follow-up skills
- Attention to detail
- Assertive.
- Conscientious.
- Patient.
- Co-operative.
- Deadline Driven
How to Apply
Click the green “Go Apply” button below to apply directly online with the employer.
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.
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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