Novartis Administrative/Secretarial Jobs in Ghana
1. Patiently scroll down and read the job description below.
2. Scroll down and find how to apply or mode of application for this job after the job description.
3. Carefully follow the instructions on how to apply.
4. Always apply for a job by attaching CV with a Cover Letter / Application Letter.
Summary
- Registration of new drug products and maintenance of approved drug licenses to ensure availability of these products in the countries.
- Maintain good relationship with the HA to enhance prompt registration of new products and maintenance of product licenses.
- Maintain all necessary Novartis databases (e.g. DRAGON) to ensure regulatory compliance at all time.
- Maintain open communication with the different stakeholders and regularly provide information when required.
- Liaison between different stakeholders on regulatory matters.
- Supporting Clinical Trial applications in Ghana.
About The Role
Major Accountabilities:
- To support the planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registration timelines.
- To ensure (thorough follow up) that documents for new registration and reregistration are requested and received to ensure submission is achieved by due dates.
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- To ensure that submissions for license renewal are done in good time before license expiry so as to achieve approvals and to avoid Top line impact due to license expiry
- To ensure submissions for production transfers and pack size extension are made and approvals received by due dates.
- To apply for and get approvals for pre-license promotion through named patient basis or orphan drugs when required.
- Ensure compliance to current local regulations and communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders.
- Support the update local/Regional Working Practices or SOPs when required.
- Ensure adherence to Global and local/regional processes.
- Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
- Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary.
- Ensure compliance to global and local KPIs.
- Review and approval of marketing promotional materials when assigned by RA Head
- Develop and maintain good working relationships with other Novartis functions/departments both locally and globally, as well as with health authority and industry bodies, such as AREPI.
- Support our distributors on regulatory issues as assigned by RA Head
- Support Novartis culture including promotion of diverse and inclusive environment, free from all forms of discrimination and harassment.
Key Performance Indicators
- Meeting the registration submission due dates for products planned for launch each year.
- Meeting the registration approval dates for products planned for launch each year.
- Meeting product re-registration due dates and ensuring that no adverse impact occurs due to loss of license
- Maintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
- Keeping and improving strong relations with Health Authority's officials.
- Achievement of Regulatory compliance deliverables as per global targets
- Address issues related to compliance with urgency with escalations as appropriate.
- Product Deliveries to the markets according to plans (no stock outs due to out of compliance)
- Share emerging regulatory intelligence with the RA Head.
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Ideal Background
Education (minimum/desirable): B. Pharm or BSc.
Languages: Fluent in English (mandatory)
Experience
- Minimum 3-5 years regulatory and drug/biologics development experience.
- Health Authority experience desirable.
- Good communication and negotiation skills.
- Good inter-personal skills.
1. Patiently scroll down and read the job description below.
2. Scroll down and find how to apply or mode of application for this job after the job description.
3. Carefully follow the instructions on how to apply.
4. Always apply for a job by attaching CV with a Cover Letter / Application Letter.
Summary
- Registration of new drug products and maintenance of approved drug licenses to ensure availability of these products in the countries.
- Maintain good relationship with the HA to enhance prompt registration of new products and maintenance of product licenses.
- Maintain all necessary Novartis databases (e.g. DRAGON) to ensure regulatory compliance at all time.
- Maintain open communication with the different stakeholders and regularly provide information when required.
- Liaison between different stakeholders on regulatory matters.
- Supporting Clinical Trial applications in Ghana.
About The Role
Major Accountabilities:
- To support the planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registration timelines.
- To ensure (thorough follow up) that documents for new registration and reregistration are requested and received to ensure submission is achieved by due dates.
ADVERTISEMENT - CONTINUE READING BELOW
- To ensure that submissions for license renewal are done in good time before license expiry so as to achieve approvals and to avoid Top line impact due to license expiry
- To ensure submissions for production transfers and pack size extension are made and approvals received by due dates.
- To apply for and get approvals for pre-license promotion through named patient basis or orphan drugs when required.
- Ensure compliance to current local regulations and communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders.
- Support the update local/Regional Working Practices or SOPs when required.
- Ensure adherence to Global and local/regional processes.
- Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
- Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary.
- Ensure compliance to global and local KPIs.
- Review and approval of marketing promotional materials when assigned by RA Head
- Develop and maintain good working relationships with other Novartis functions/departments both locally and globally, as well as with health authority and industry bodies, such as AREPI.
- Support our distributors on regulatory issues as assigned by RA Head
- Support Novartis culture including promotion of diverse and inclusive environment, free from all forms of discrimination and harassment.
Key Performance Indicators
- Meeting the registration submission due dates for products planned for launch each year.
- Meeting the registration approval dates for products planned for launch each year.
- Meeting product re-registration due dates and ensuring that no adverse impact occurs due to loss of license
- Maintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
- Keeping and improving strong relations with Health Authority's officials.
- Achievement of Regulatory compliance deliverables as per global targets
- Address issues related to compliance with urgency with escalations as appropriate.
- Product Deliveries to the markets according to plans (no stock outs due to out of compliance)
- Share emerging regulatory intelligence with the RA Head.
ADVERTISEMENT - CONTINUE READING BELOW
Ideal Background
Education (minimum/desirable): B. Pharm or BSc.
Languages: Fluent in English (mandatory)
Experience
- Minimum 3-5 years regulatory and drug/biologics development experience.
- Health Authority experience desirable.
- Good communication and negotiation skills.
- Good inter-personal skills.
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