Regulatory Affairs Specialist M/F

at  PRODUCTLIFE Group

About the job
In the context of our growing activities, we are looking for a Regulatory Affairs Specialist M/F to join our teams in South Africa.
You will integrate a team of Regulatory Affairs professionals dedicated to one of our new main clients across the globe and will have the mission to develop PLG’s local South Africa Regulatory Affairs presence, taking responsibility for new regulatory activities related to South Africa for this main client and other several clients.
Responsibilities
Regulatory in country affiliate activities
Local stakeholder interface
Operational liaison with 3rd Parties
Regulatory Assessment for Quality and Safety changes (including labelling updates and non CMC administrative changes)
Creation/update of Country Label Deviation
Update and approval of local artworks
Provision of local regulatory intelligence
Update of local site licenses (GMP site renewals)
Regulatory review of local promotional materials via PromoMats
Local Regulatory SOP review and update
Regulatory activities for new launches (preparation of Marketing Authorization Applications)
Coordination of Response to Questions
Preparation/update Product Information
Preparation /update local abbreviated PI (if applicable)
Fee calculation
Preparation of Renewal Procedure (eg. local document identification and preparation)
Preparation for Variations including. RtQs, requesting/securing centrally provided documentation
Preparation and submission of Technical/Site Transfer Applications
Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of MAs
Assisting with license applications as required.
Responding to internal requests for technical and/or regulatory information.
Providing support during external and unannounced audits.
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
General regulatory administration duties and compliance requirements
Preparation for Annual Safety Updates/HA instructed safety updates
Informing reliant markets of changes to reference product
PQR local submissions (when applicable)
Responding to requests from Medical information (when applicable)
Provision of regulatory data for PV reporting
Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc
Education
At least a Bachelor’s Degree in Life Sciences, ideally a Pharmacy Degree
Experience
At least 5 years of experience in RA in a Pharmaceutical Company or Service Provider
South Africa LifeCycle Maintenance (LCM) experience
Experience in the management of artwork generation/ labelling/creation/update of product information (at least 3-5 years)
Experience in project management
Experience in the new registrations of drug products is preferable
Experience of Pharmacovigilance (PV) would be beneficial
Experience of promotional/non-promotional activities would be an advantage (at least 3-5 years)
Skills

HARD/TECHNICAL SKILLS:

Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in South Africa and ideally in the EU region
Knowledge of South African regulation for pharmaceuticals (NCE, Biologicals and Biotech) and ideally for Medical Devices, Combination products and Cosmetics
Strong computer skills, including MS Office applications, data and document management systems
Fluency in Afrikaans and English

SOFT SKILLS:

Excellent communication skills
Excellent organizational and interpersonal skills
Very good coordination skills
A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
Ability to work well within a team and autonomously
Ability to prioritize different workloads/multi-task
Process orientated with good attention to detail
Solution-driven
About us
ProductLife Group provides world-class regulatory outsourcing and consulting services for the global life sciences industry. Headquartered in Paris, ProductLife Group has offices in countries across Europe, the Middle East, Asia, Africa, Latin America, and North America.
ProductLife Group was founded in 1994 and has since become a global industry leader, thanks to the firm’s driven and talented employees, who are always motivated by a supportive team environment as well as opportunities to learn and to grow professionally. Employees and company partners are located in offices worldwide to support clients and drive continued growth.
If you’re enthusiastic, if you welcome challenges, and if you want to grow professionally with a management team committed to your development, apply to join us

Please refer the Job description for details