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Midrand: Regulatory Affairs Pharmacist – Otc posted by Emporium

Date 2024-11-24
Job Title Regulatory Affairs Pharmacist – Otc
Employer Emporium
More Information
Salary 900000
Category Medical
Location Gauteng
/ Midrand

Job Summary

Regulatory Affairs Pharmacist (OTC) – POS24328

Area: Midrand

Salary R900 – R1m

Qualifications

  • Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards
  • Good Manufacturing Practices (GMP)
  • Pharmaceutical production experience or exposure to supplement regulatory knowledge.

 

 

To apply for this position: Send MS Word format CV to Emporium
Regulatory Affairs Pharmacist – Otc position available in Gauteng, Midrand. This job position was posted by Emporium. The job has been posted as a premium ad on 2024-11-24 at 09:06:05 in the Medical category

Click Go Apply to apply online!


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Apply directly on jobmail for this position
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Each job post has a link to take you directly to the original post to apply on their website or the original website where the post came from.


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Posted in Jobs in Gauteng, Jobs in Midrand

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Midrand: Regulatory Affairs Pharmacist – Otc posted by Emporium

Date 2024-11-24
Job Title Regulatory Affairs Pharmacist – Otc
Employer Emporium
More Information
Salary 900000
Category Medical
Location Gauteng
/ Midrand

Job Summary

Regulatory Affairs Pharmacist (OTC) – POS24326

Area: Midrand

Salary R900 – R1m

Qualifications

  • Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards
  • Good Manufacturing Practices (GMP)
  • Pharmaceutical production experience or exposure to supplement regulatory knowledge.

Key Job Outputs

  • Manage work streams for- and report on the assigned portfolio of products:
  • Internal product queries from relevant departments
  • External product queries from the SAHPRA, other MRA’s and third-party stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary medicines and medical devices.
  • Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
  • Prepare the registration applications for submission to the regulatory authorities
  • Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc.
  • Update and maintain databases, trackers and systems for all regulatory related activities.
  • Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
  • Internal training and mentoring of peers when required.
  • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
  • Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Support activities such as internal audits or regulatory agency inspections
  • Ensure alignment of personal and company values
  • Core competencies
  • Experience in use of CTD software builder and compilation of eCTD dossier applications.
  • IT skills including Microsoft Office
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • Active learning
  • Strategic thinking
  • Ability to cope with a high degree of complexity and change
  • Cross Functional skills: Ability to network, liaise and negotiate with others
  • Ability to set standards and objectives and monitor progress
  • Complex problem solving and decision-making skills
  • Customer relationships
  • Development of people
  • Must demonstrate responsibility, excellence and collaboration and align with Company values

Closing Date: 31 October 2024

To apply for this position: Send MS Word format CV to Emporium
Regulatory Affairs Pharmacist – Otc position available in Gauteng, Midrand. This job position was posted by Emporium. The job has been posted as a premium ad on 2024-11-24 at 09:06:05 in the Medical category

Click Go Apply to apply online!

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You might also like to look at the available jobs in the same area.

Apply directly on jobmail for this position
Some posts have contact information included with other instructions. All applicants are urged to read the instructions carefully.
We will list jobs at the bottom of each job, so feel free to scroll down and continue your search.

We do not accept any job applications and merely offer the service of daily jobs being mined and displayed on our job portal.
Each job post has a link to take you directly to the original post to apply on their website or the original website where the post came from.


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Error making API request.

Share this to someone who needs a job:
Posted in Jobs in Gauteng, Jobs in Midrand

More Jobs in Your Area

Midrand: Regulatory Affairs Pharmacist – Otc posted by Emporium

Date 2024-11-24
Job Title Regulatory Affairs Pharmacist – Otc
Employer Emporium
More Information
Salary 750000
Category Sales Marketing
Location Gauteng
/ Midrand

Job Summary

Regulatory Affairs Pharmacist – OTC – POS24203

Based: Midrand

Salary: R750K

Qualifications/experience

  • Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
  • 3 to 5 years’ experience in Regulatory Affairs, preferably in human medicines
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle
  • Sound project management capabilities
  • Proven ability to consistently deliver to quality, time and cost standards

Key Job Outputs

  • Manage work streams for- and report on the assigned portfolio of products:
  • Assisting with internal product queries from relevant departments
  • Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
  • Establish regulatory priorities and allocate resources and workloads
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
  • Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products
  • Conduct dossier due diligence to ensure all data gaps are addressed
  • Prepare the registration applications for submission to the regulatory authorities
  • Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
  • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
  • Internal training and mentoring
  • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
  • Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Support activities such as internal audits or regulatory agency inspections
  • Ensure alignment of personal and company values
  • Core competencies
  • Experience in use of CTD software builder and compilation of eCTD applications.
  • IT skills
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • Basic cost management skills
  • Active learning
  • Strategic thinking
  • Ability to cope with a high degree of complexity and change
  • Cross Functional skills: Ability to network, liaise and negotiate with others
  • Ability to set standards and objectives and monitor progress
  • Complex problem solving and decision-making skills
  • Customer relationships
  • Development of people
  • Must demonstrate responsibility, excellence and collaboration and align with Company values
  • Interested parties who meet the above requirements must email

Closing Date: 25 July 2024

To apply for this position: Send MS Word format CV to Emporium
Regulatory Affairs Pharmacist – Otc position available in Gauteng, Midrand. This job position was posted by Emporium. The job has been posted as a premium ad on 2024-11-24 at 09:05:58 in the Sales Marketing category

Click Go Apply to apply online!


You might also like to look at the available jobs in the same area.



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Select one of the buttons below to browse for more available jobs.









Apply directly on jobmail for this position
Some posts have contact information included with other instructions. All applicants are urged to read the instructions carefully.
We will list jobs at the bottom of each job, so feel free to scroll down and continue your search.

We do not accept any job applications and merely offer the service of daily jobs being mined and displayed on our job portal.
Each job post has a link to take you directly to the original post to apply on their website or the original website where the post came from.


Here are some more related positions


Gauteng: Regulatory Affairs Pharmacist – Urgently Needed posted by AN11180725734

Were hiring a Regulatory Pharmacist to join a top South African pharmaceutical manufacturer. This role is crucial in ensuring the approval and registration of life-saving medicines with key authorities.About the Company:Our client is a leading pharmaceutic


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Regulatory Affairs Pharmacist

Midrand: Senior Regulatory Affairs Pharmacist: Otc

Senior Regulatory Affairs Pharmacist: OTC -POS24206 Area : Midrand Salary R950 R1m Qualifications Bachelors Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council -5 years experience in Regulatory Affairs, preferab


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Senior Regulatory Affairs Pharmacist

Midrand: Regulatory Affairs Pharmacist – Otc

Regulatory Affairs Pharmacist OTC POS24203 Based : Midrand Salary : R750K Qualifications/experience Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council 3 to 5 years experience in Regulatory Affairs, pre

View Job  Johannesburg: Internal Audit Manager: Credit posted by Hire Resolve

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Regulatory Affairs Pharmacist – Otc

Parow: Regulatory Affairs Officer posted by O`Brien Recruitment

Regulatory Affairs OfficerKey ResponsibilitiesResearch and interpret global regulatory and legislative requirements, summarising them to meet business needs.Manage product and supplement registrations internationally by initiating, compiling, approving, an


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Regulatory Affairs Officer

Johannesburg: Regulatory Affairs Manager posted by Curiska

Hiring: Regulatory Affairs ManagerLocation: Midrand, South Africa As a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements. Ke


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Regulatory Affairs Manager

Pretoria: Head Of Compliance & Regulatory Affairs posted by Isilumko Staffing

Responsibilities:To ensure compliance with applicable legislation in an efficient and effective manner.Ensuring compliance with laws, regulations and industry regulatory requirements by updating policies and procedures.Developing policies.Providing input


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Head Of Compliance & Regulatory Affairs

Pretoria: Head Of Compliance & Regulatory Affairs posted by Isilumko Staffing

Duties & Responsibilities:As a Compliance Officer at a leading FSP, you will play a pivotal role in ensuring that our organization complies with relevant legislation efficiently and effectively. Your responsibilities will include:Providing legal advice


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Head Of Compliance & Regulatory Affairs

Midrand: Senior Regulatory Affairs Pharmacists posted by JorDan HR

Qualifications Bachelors Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council Experience 5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devic


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Senior Regulatory Affairs Pharmacists

Midrand: Regulatory Affairs Manager posted by JorDan HR

Qualifications Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council Relevant experience Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines Demonstrable experience across t


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Regulatory Affairs Manager

Midrand: Regulatory Affairs Manager posted by Hire Resolve

Hire Resolve`s client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenanc


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Regulatory Affairs Manager

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