Regulatory Affairs Manager - Sandton
Salary Negotiable
Sandton,
Gauteng
more than 14 days ago
REPORTS TO : RESPONSIBLE PHARMACIST & HEAD: RA, QA & COMPLIANCE
DIVISION : PHARMA
JOB OBJECTIVE
To ensure that all Ascendis Pharma products on the market, are safe and effective and comply with Regulatory Authority requirements.
TASK DESCRIPTION
• Plan and monitor the departmental budget on an ongoing basis.
• Develop Regulatory strategies and timelines for product development and product improvement projects.
• Lead and guide product dossier submissions to the relevant Regulatory Authorities.
• Lead and guide responses to resolutions and queries from Regulatory Authorities.
• Monitor communication and liaison with these authorities during the registration process to ensure timelines are met.
• Review, approve and provide guidance for labelling and advertising of Ascendis Pharma products.
• Assist in Regulatory Authority inspections and preparedness activities.
• Interact with Regulatory Authority officials on product approval and compliance issues.
• Plan and monitor a Registration Dossier maintenance program for South Africa and designated export territories in compliance with government / regulatory requirements and company policies.
• Provide guidance on regulatory compliance.
• Evaluate change controls and provide final regulatory assessment.
• Review and provide input on departmental policies and procedures.
• Provide input and comment on regulations and standards which may affect Ascendis Pharma products. Participate in industry related working groups.
• Oversee the initiation and development of a Medicine Safety / Pharmacovigilance Operational System.
• Serve as the company point of contact / spokesperson for post marketing safety and pharmacovigilance issues for all Ascendis Pharma products.
• Maintain Company Package inserts and Patient Information Leaflets and evaluation of product labelling to ensure healthcare providers and patients are appropriately informed regarding the safety profile of Ascendis Pharma products.
• Provide coaching / mentoring to all Regulatory personnel.
EDUCATION AND KEY EXPERIENCE
• Pharmacist, Registered with the South African Pharmacy Council
• Minimum 5 years’ Experience in Regulatory Affairs in the Pharmaceutical Environment
• Ability to lead and manage people
• Production and QA Experience an advantage
• CAMS and SSA Regulatory experience an advantage
DIVISION : PHARMA
JOB OBJECTIVE
To ensure that all Ascendis Pharma products on the market, are safe and effective and comply with Regulatory Authority requirements.
TASK DESCRIPTION
• Plan and monitor the departmental budget on an ongoing basis.
• Develop Regulatory strategies and timelines for product development and product improvement projects.
• Lead and guide product dossier submissions to the relevant Regulatory Authorities.
• Lead and guide responses to resolutions and queries from Regulatory Authorities.
• Monitor communication and liaison with these authorities during the registration process to ensure timelines are met.
• Review, approve and provide guidance for labelling and advertising of Ascendis Pharma products.
• Assist in Regulatory Authority inspections and preparedness activities.
• Interact with Regulatory Authority officials on product approval and compliance issues.
• Plan and monitor a Registration Dossier maintenance program for South Africa and designated export territories in compliance with government / regulatory requirements and company policies.
• Provide guidance on regulatory compliance.
• Evaluate change controls and provide final regulatory assessment.
• Review and provide input on departmental policies and procedures.
• Provide input and comment on regulations and standards which may affect Ascendis Pharma products. Participate in industry related working groups.
• Oversee the initiation and development of a Medicine Safety / Pharmacovigilance Operational System.
• Serve as the company point of contact / spokesperson for post marketing safety and pharmacovigilance issues for all Ascendis Pharma products.
• Maintain Company Package inserts and Patient Information Leaflets and evaluation of product labelling to ensure healthcare providers and patients are appropriately informed regarding the safety profile of Ascendis Pharma products.
• Provide coaching / mentoring to all Regulatory personnel.
EDUCATION AND KEY EXPERIENCE
• Pharmacist, Registered with the South African Pharmacy Council
• Minimum 5 years’ Experience in Regulatory Affairs in the Pharmaceutical Environment
• Ability to lead and manage people
• Production and QA Experience an advantage
• CAMS and SSA Regulatory experience an advantage
Recruiter: Laz Badirwane