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South Africa: Regulatory Affairs Manager posted by Emporium

Date 2024-12-25
Job Title Regulatory Affairs Manager
Employer Emporium
More Information
Salary 100000
Category Medical
Location South Africa
/ South Africa

Job Summary

Regulatory Affairs Manager (POS24277)

Aeroton

Salary R1m to R1.2 mil per annum
 
 

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
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
View Job  South Africa: Pharmacist Assistant posted by Signa Opportunity

Closing Date: 12 August 2024

To apply for this position: Send MS Word format CV to Emporium
Regulatory Affairs Manager position available in South Africa, South Africa. This job position was posted by Emporium. The job has been posted as a premium ad on 2024-12-25 at 09:09:25 in the Medical category

Click Go Apply to apply online!

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Some posts have contact information included with other instructions. All applicants are urged to read the instructions carefully.
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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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Posted in Jobs in South Africa

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South Africa: Regulatory Affairs Manager posted by Emporium

Date 2024-12-25
Job Title Regulatory Affairs Manager
Employer Emporium
More Information
Salary 1500000
Category Medical
Location South Africa
/ South Africa

Job Summary

Regulatory Affairs Manager (POS24191)

Area: Aeroton

R1,5 – 1,7k pa

Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Qualifications/experience •

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

Key Job Outputs 

  • Manage work streams for- and report on the assigned group of portfolios
  • 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 NBD 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.
  • Manage 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 application will be an advantage.
  • IT skills
  • Leadership skills, management of personnel resources
  • Ability to prioritise and work to tight deadlines
  • Systems and operations analysis
  • 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
View Job  South Africa: Pharmacist Assistant posted by Signa Opportunity

Closing date: 14 July 2024

Send all CV’s to Emporium
Regulatory Affairs Manager position available in South Africa, South Africa. This job position was posted by Emporium. The job has been posted as a premium ad on 2024-12-25 at 09:09:24 in the Medical category

Click Go Apply to apply online!

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



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.

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Posted in Jobs in South Africa

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