Regulatory Affairs Strategic Manager
3 days ago
Job Description:
At Unique Personnel Ltd, we are seeking a highly skilled Regulatory Affairs Portfolio Lead to join our team. This role is responsible for managing work streams and reporting on assigned portfolios of products.
Main Responsibilities:
- Assisting with internal product queries from relevant departments
- Assisting with external product queries from the SAHPRA, other MRAs, and third-party stakeholders
- Establishing regulatory priorities and allocating resources and workloads
- Reviewing regulatory agency submissions of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Artwork reviews and approvals
- Co-ordinating and submitting new product applications in South Africa and other applicable territories
- Developing regulatory strategies and implementation plans for the preparation and submission of new products
- Conducting dossier due diligence to ensure all data gaps are addressed
- Preparing registration applications for submission to the regulatory authorities
- Working in collaboration with internal and external stakeholders to assess regulators' submissions requirements
- Maintaining current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry
Requirements:
- 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
- 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
Estimated Salary: R850,000 - R1,200,000 per annum (depending on experience)
-
Strategic Affairs Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Performer Recruitment and Consulting Full timeAbout the RoleWe are seeking a highly skilled Strategic Affairs Manager to join our team at Performer Recruitment and Consulting.Job DescriptionThe successful candidate will be responsible for evaluating the operational landscape within South Africa, identifying commercial risks and opportunities, and developing strategies to mitigate risks and capitalize on...
-
Regulatory Affairs Manager Position
3 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeCuriska is seeking a Senior Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster.The estimated salary for this position is R1,200,000 - R1,800,000 per annum, depending on experience.We are looking for a detail-oriented individual with at least 10 years of experience in Regulatory Affairs, specifically in human...
-
Pharmaceutical Regulatory Affairs Manager
3 weeks ago
Johannesburg, Gauteng, South Africa ES Recruitment Full timeJob Title: Pharmaceutical Regulatory Affairs ManagerWe are seeking a seasoned Pharmaceutical Regulatory Affairs Manager to lead our regulatory compliance and quality assurance efforts. As a key member of our team, you will be responsible for ensuring the highest level of quality and compliance in our regulatory processes.**Responsibilities:**Lead regulatory...
-
Strategic Medical Affairs Director
2 weeks ago
Johannesburg, Gauteng, South Africa Carlysle Human Capital Full timeWe are Carlysle Human Capital, a leading recruitment agency dedicated to providing innovative solutions for our clients and candidates. As a Strategic Medical Affairs Director, you will play a pivotal role in shaping the future of healthcare solutions with our esteemed client.About the RoleThe ideal candidate should have at least 35 years of experience in...
-
Compliance and Regulatory Affairs Officer
4 weeks ago
Johannesburg, Gauteng, South Africa TalentCru Full timeTalentCru Overview:TalentCru is a leading recruitment agency specializing in placing top talent in various industries. We are committed to excellence and strive to provide the best possible service to our clients.We are seeking an experienced Administrator to join our team and contribute to our success. The successful candidate will be responsible for...
-
Medical Affairs Leadership Specialist
1 month ago
Johannesburg, Gauteng, South Africa Carlysle Human Capital Full timeMedical Affairs Manager RoleWe are seeking a seasoned Medical Affairs professional to drive strategic initiatives and elevate our healthcare solutions. As a Medical Affairs Manager, you will play a pivotal role in shaping our medical strategy.Key ResponsibilitiesContent Creation: Develop insightful medical blogs to share knowledge and industry trends,...
-
Student Affairs Leader
3 weeks ago
Johannesburg, Gauteng, South Africa DPT Recruitment Full time**Job Title:** Senior Director: Student Affairs**Location:** Auckland Park Kingsway Campus, South Africa**Salary Range:** R1 200 000 - R1 800 000 per annumWe are seeking a highly experienced and visionary leader to join our team as the Senior Director: Student Affairs. The successful candidate will be responsible for creating a holistic university experience...
-
Senior University Affairs Director
4 weeks ago
Johannesburg, Gauteng, South Africa DPT Recruitment Full timeAbout the Role We are seeking a highly motivated and experienced leader to join our team as Senior University Affairs Director at DPT Recruitment.The successful candidate will be responsible for leading the Student Affairs division, creating a holistic university experience for students by providing support, resources, and opportunities that contribute to...
-
Johannesburg, Gauteng, South Africa Watershed Consulting Full timeJob DescriptionWe are seeking an experienced Medical Affairs Manager to join our team at Watershed Consulting.ResponsibilitiesDevelop and implement medical strategy for product launches, collaborating with cross-functional teams.Liaise with Regulatory Affairs and Marketing departments to ensure compliance and effective messaging.Contribute to legal affairs...
-
Regulatory Quality Assurance Specialist
3 weeks ago
Johannesburg, Gauteng, South Africa ES Recruitment Full timeJob Title: Regulatory Quality Assurance SpecialistWe are seeking an experienced Regulatory Quality Assurance Specialist to join our team at ES Recruitment. As a key member of our organization, you will be responsible for ensuring the highest level of quality and compliance in our regulatory processes.**About the Role:**Act as Responsible Pharmacist for the...
-
Medical Affairs Strategy Expert
7 days ago
Johannesburg, Gauteng, South Africa Carlysle Human Capital Full timeWe are seeking a highly skilled Medical Affairs Strategy Expert to join our team at Carlysle Human Capital. As a Medical Affairs Manager, you will play a pivotal role in shaping the future of healthcare solutions.This is an exceptional opportunity for a motivated individual with a strong background in medicine and experience in the pharmaceutical industry....
-
Senior Stakeholder Manager
4 weeks ago
Johannesburg, Gauteng, South Africa Performer Recruitment and Consulting Full timeJob DescriptionAs a Senior Stakeholder Manager, you will play a crucial role in shaping the operating environment for our company in South Africa. Your primary responsibility will be to anticipate and assess changes that may impact our business operations, identifying commercial risks and opportunities.We are looking for an experienced professional with a...
-
Regulatory Affairs Assistant
4 weeks ago
Johannesburg, Gauteng, South Africa Signa Opportunity Full timeAbout the JobWe are seeking an Environmental Assistant to join our team at Signa Opportunity. The successful candidate will have a strong understanding of environmental regulations and be able to effectively communicate findings and recommendations through reports and presentations.Key Responsibilities:Conducting environmental screenings and scopingManaging...
-
Senior Compliance Officer Role
3 weeks ago
Johannesburg, Gauteng, South Africa Curiska Full timeA challenging role for a skilled Regulatory Affairs Manager has become available at Curiska.This position comes with an attractive salary range of R1,200,000 - R1,800,000 per year, commensurate with experience.We require a highly organized individual with extensive experience in Regulatory Affairs, particularly in the fields of human medicine and...
-
Strategic Operations Manager
4 weeks ago
Johannesburg, Gauteng, South Africa Communicate Recruitment Full timeAbout Us: Communicate Recruitment is a leading staffing solutions company, providing top talent to various industries. Our team is dedicated to delivering exceptional service and results-driven solutions.Job Title: Strategic Operations ManagerSalary: R850,000 - R1,200,000 per annum (dependent on experience)Job Description:As a Strategic Operations Manager at...
-
Strategic Leadership Manager
3 weeks ago
Johannesburg, Gauteng, South Africa The Recruitment Council Full timeAbout the JobWe are seeking a dynamic leader to fill the position of Chief Growth Officer at our leading financial services organization. This is a strategic leadership role suited for an individual ready to make a significant impact on the future of our company.Job Description:Cultivate a client service excellence culture that fosters rewarding...
-
Strategic Investment Manager
2 weeks ago
Johannesburg, Gauteng, South Africa Network Recruitment Full timeWe are seeking a highly skilled and experienced Strategic Investment Manager to join our team at Network Recruitment.About the RoleThis is a challenging and rewarding opportunity for an individual with a strong background in corporate finance or leveraged funds, preferably with 57 years of experience.The ideal candidate will have a proven track record of...
-
Pharmaceutical Medical Liaison Specialist
2 months ago
Johannesburg, Gauteng, South Africa Watershed Consulting Full timeWatershed ConsultingWe are seeking a highly skilled Pharmaceutical Medical Liaison Specialist to join our team.About the Role:The successful candidate will be responsible for writing engaging medical blogs, collaborating with Regulatory Affairs and marketing teams on product launches, detail aids, training, and oversight of training.In addition, they will...
-
Strategic Mine Development Manager
3 weeks ago
Johannesburg, Gauteng, South Africa The Legends Agency Full timeThe Legends Agency is hiring a Strategic Mine Development Manager to lead our North American operations. The successful candidate will be responsible for designing innovative mining layouts and schedules that maximize resource extraction and minimize costs.About the Role:Lead Mine Planning: Develop and implement strategic mine plans that optimize open-pit...
-
Strategic Financial Director
2 weeks ago
Johannesburg, Gauteng, South Africa Salix Recruitment Full timeJob Overview:Salix Recruitment is seeking an experienced Divisional Chief Financial Officer to lead our financial function in Kempton Park, East of Johannesburg. This role offers a unique opportunity to drive strategic growth and excellence.About the Role:This challenging position requires a dynamic financial leader who can oversee financial reporting,...