South Africa: Regulatory Affairs Manager posted by Emporium

Date	2024-11-24
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: Credit Analyst posted by SET Consulting

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 2024-11-24 at 09:05:59 in the Medical category

Click Go Apply to apply online!

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Posted in Jobs in South Africa

South Africa: Regulatory Affairs Manager posted by Emporium

Date	2024-11-24
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

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 2024-11-24 at 09:05:58 in the Medical category

Click Go Apply to apply online!

View Job South Africa: Packing Operations Manager Â€“ Fruit & Vegetables posted by Farm Manager SA

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.

Here are some more related positions

Gauteng: Regulatory Affairs Pharmacist – Urgently Needed posted by AN11180725734

View Job
Regulatory Affairs Pharmacist – Urgently Needed

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

View Job
Regulatory Affairs Officer