52 Pharmaceutical Management jobs in Gauteng

Reference: DBN -SS-4

Job Purpose:
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.

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.

Key Responsibilities:

1. Manage work streams for- and report on the assigned group of portfolios
2. Assisting with internal product queries from relevant departments
3. Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
4. Establish regulatory priorities and allocate resources and workloads
5. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
6. Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to:
1. Develop regulatory strategies and implementation plans for the preparation and submission of new products
2. Conduct dossier due diligence to ensure all data gaps are addressed
3. Prepare the registration applications for submission to the regulatory authorities
4. Work in collaboration with NBD to assess regulator’s submissions requirements
5. Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
6. Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
7. Internal training and mentoring
8. Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
9. Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
10. Manage activities such as internal audits or regulatory agency inspections
11. Ensure alignment of personal and company values

Requirements:

1. Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
2. Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
3. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
4. Sound project management capabilities
5. Proven ability to consistently deliver to quality, time and cost standards Professional people management experience

Competencies:

1. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
2. IT skills
3. Leadership skills, management of personnel resources
4. Ability to prioritise and work to tight deadlines
5. Systems and operations analysis
6. Active learning
7. Strategic thinking
8. Ability to cope with a high degree of complexity and change
9. Cross Functional skills: Ability to network, liaise and negotiate with others
10. Ability to set standards and objectives and monitor progress
11. Complex problem solving and decision-making skills
12. Customer relationships
13. Development of people
14. Must demonstrate responsibility, excellence and collaboration and align with Company values

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

HR Services, Recruitment & Selection

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .