Job Description

.Job Overview:As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance in SEA Cluster. You will ensure that the company complies with all regulations and maintains Servier's pharmacovigilance requirements.Duties and Responsibilities:

• Lead, manage, and execute strategic direction as the regulatory affairs manager.
• Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
• Provide input to the regulatory strategy in line with business objectives.
• Manage and implement safety updates where required.
• Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
• Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
• Write and develop SOPs in line with Global SOPs.
• Manage internal and external audits (e.g., Global & SAHPRA)
• Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
• Manage product complaints and deviations.
• Maintain regulatory documentation filing system.
• Ensure regulatory compliance and quality-related records are available and retained.
• Coordinate product recall or market withdrawal when necessary.
• Obtain and distribute updated information on domestic and international laws.
• Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
• Conduct pharmacovigilance training for local staff14.
• Answer requests from the Regulatory Authority in cooperation with Global Safety
• Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
• Identify areas for improvement within the quality system and implement corrective and preventive actions.
• Provide training to staff on quality standards, regulatory requirements, and best practices.
• Identify areas for improvement within the quality system and implement corrective measures.
• Maintain and manage quality related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
• Ensure compliance with environmental regulations and standards at local, national, and international levels.
• The manager will also manage releases of finished products, customer complaints etc.

Requirements:Education:

• B. Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC)

Experience:

• Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience

Skills:

• Product registration and dossier maintenance.
• Pharmacovigilance experience and knowledge of SAHPRA submission portals.
• Launch procedures for new products
• QA processes, APQRs, customer complaints.
• Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa
• Microsoft Office Suite proficiency.
• Familiarity with ZAZIBONA processes and eCTD submissions

Personal Qualities:

• Focus
• Attention to detail
• Flexibility
• Planning and organization
• Communication
• Teamwork
• Confidentiality
• Agility and ability to work in a fast-paced environment
• Systems knowledge
• Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
• Familiar with ZAZIBONA processes
• Competent and experienced in eCTD submissions.

DISPENSIBLE QUALITIES:

• Focus
• Attention to detail
• Flexibility
• Planning and organisation
• Communication
• Teamwork
• Confidentiality
• Agile and able to work in a fast pace

About Servier: At Servier, we are committed to therapeutic progress to serve patient needs. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages development. We offer tailor-made onboarding journeys, mobility opportunities, quality training, responsible management, and a team spirit-focused workplace.Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

Servier