REGULATORY AFFAIRS PORTFOLIO MANAGER
JHB
Pharmaceutical Sector
Reports to Regulatory Affairs Manager

Leading pharmaceutical manufacturer seeks suitably qualified / experienced Regulatory Affairs Portfolio Manager to join their dynamic team and resume responsibility for management of all pending registrations of Company products with MCC/SAHPRA

MINIMUM REQUIREMENTS:
• Bachelor of Pharmacy Degree
• Registered with the SAPC (South African Pharmacy Council)
• At least 3 – 5 years significant previous Regulatory Affairs experience
• Experience in Pharmaceutical Industry essential
• Good written and communication skills
• Strong organizational and administration skills
• Inter personal skills
• Telephone skills
• Attention to Detail
• Good organizing, a hands-on person, able to multi-task
• Ability to prioritize duties and responsibilities
• Able to function effectively under pressure – commit to and meet tight schedules
• Able to work autonomously under supervision
• Good time management and planning skills
• Must be a team player / good interpersonal abilities
• Enquiring mind with attention to detail
• Positive attitude, flexible and efficient in approach to work.
• Strong interpersonal skills with a customer relationship focus.
• Attention to detail and accuracy.
• Professional and ethical verbal and written communication skills
• Ability to act with integrity when working with highly sensitive and confidential matters
• High level of professionalism
• Takes action with integrity

KEY RESPONSIBILITIES WILL INCLUDE:

• New product submissions & registrations with South African Regulatory Authorities Maintenance of registered/old products
• Due diligence of new dossiers
• Initiate and manage Change Control Procedures for existing registered products
• Review and approval of printed packaging components
• Updating of Standard Operating Procedures
• Liaise with MCC, SAPC, DoH and other Regulatory Authorities
• Approval of promotional material
• Liaise with Marketing Department - Regular meetings with marketing department to determine priorities for the registration process.
• Assist with technical agreements with third party contractors.
• Dossier conversions to CTD
• Assistance with tender applications
• Update and maintain appropriate tracking systems/documents to assure accuracy and currency