MedicalCareers

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RA Portfolio Manager – Pharmaceutical

Job Overview

More Information

 multinational pharmaceutical company has an opportunity for  a RA POrtfolio Manager to
co-ordinates and manage the registration process for new product submissions, as well as maintenance of the product life cycle of all products; this includes the compilation of dossiers for submission to the Regulatory Authority/ies and providing regulatory, scientific, medical, marketing, technical and public relations support.
Support all DRA Initiatives and projects where and when required.

Major Accountabilities
1. New Products – Submissions for registration:
• To achieve timeous registration of all products in accordance with the requirements of the Regulatory Authorities (RA) in South Africa and in foreign countries where registration is applied for, in compliance with the standards set by head office;
• Compilation of registration documents for Global Generics in accordance with the requirements of the relevant registration and development group.

2. Product maintenance – Regulatory Compliance:
• To ensure and achieve timeous submission and approval of amendments/variations for registered products by submitting quality documents in accordance with the requirements of the Regulatory Authorities in South Africa and in foreign countries where registration is achieved, and standards set by Group International and Local divisions.
• Amendment of registration dossiers for Global Generics Sector in accordance with the requirements of the relevant registration and development group.

3. Special activities: To provide the technical, regulatory and other relevant information as required by different departments and sectors, internationally and locally, in support of DRA initiatives and special activities:

• To timeously provide accurate information to satisfy the technical and information requirements of different departments internationally and locally, as well as other stakeholders
• To document and report on the relevant DRA activities
• To provide and ensure a high level of service, both to our internal and external Customers
• To provide marketing support by review of promotional material and support to brand teams.

4. Networks/ Liaison: To build and maintain good relationships within the local and global organization and to contribute to a positive company image.

5. Corporate Governance: To take responsibility for Corporate Citizenship within the sphere of influence and control, and to enforce the Code of Conduct and monitor employees’ activities within the spirit of the company’s policy.

Minimum requirements          Qualifications:

Minimum:

  • B. Pharm, Post-grad experience may be beneficial
  • Experience: 2 years RA experience, preferably all-round RA experience i.e. new submissions, quality amendments, safety label updates, eCTD submissions, artwork approvals, promotional material reviews.
  • Knowledge of Artwork management process may be beneficial.

Send your updated CV  to Vicki  at vicki@medicalcareers.co.za

Subject : RA Pharm

Successful applicants will be contacted within 10 days.

Only candidates can apply for this job.
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