Regulatory Affairs Portfolio Lead
Jordan HR
- R Undisclosed
- Permanent Intermediate position
-
Midrand
- Posted 24 Apr 2025 by Jordan HR
- Expires in 19 days
-
Job 2607707 - Ref CT004991
About the position
A pharmaceutical client is looking for a Regulatory Affairs Portfolio Lead to Support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory 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
- Bachelor’s degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Required experience
- 3 years’ experience in Regulatory Affairs, preferably in human medicines with experience across product development, commercialisation and maintenance lifecycle
- Experience in quality driven processes such as risk management, change control, deviations, CAPA’s, Root cause investigations
- Additional experience in African territories is preferable.
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
Desired Skills:
- CTD
- IT Skills
- regulatory affairs
- portfolio lead
Jordan HR
About the agency
JorDan HR believes that in order to provide clients with optimum solutions to human
capital requirements, it is necessary to gain thorough understanding of the clients’
business and needs. Designated consultants spend time on site, acquiring
knowledge of the company culture, working environment and expectations of the
client. In this way a relationship based on knowledge, trust and integrity is built and
a long term business partnership evolves.
O U R M I S S I O N
To enhance our candidates’ lives as well as contributing positively to our
clients’ bottom line, our established national footprint offers dedicated
personal service, strong relationship building, ethical business practices,
networking and professional search and recruitment, adding value within our
chosen speciality industries.
O U R V I S I O N
To continue being a Leading Recruitment Business Partner for clients and
candidates driven by passion, knowledge and expertise. To ultimately be
respected and relied upon to be the “BEST GO TO SERVICE PROVIDER” for all
recruitment needs.
T A R G E T M A R K E T S A N D I N D U S T R Y C L I E N T B A S E
Pharmaceutical / Medical / Healthcare
FMCG / Retail
Sales and Marketing
Freight Forwarding / Ship’s Agency / Transport /
Supply Chain / Warehousing / Distribution /
Logistics / Courier
Renewable Energy / Wind / Solar
Finance and Accounting
Information Technology
Office Administration
Mining / Engineering / Technical / Manufacturing / Health & Safety
Insurance
Motoring
Aviation / Airlines / Car Rental Industry
Human Resources
Legal
Construction / Security
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