Regulatory Affairs Manager at Roche

Key Responsibilities
Effectively develops, implements and manages regulatory strategies and activities

• Stays abreast of internal and external developments, trends and other dynamics which may influence pipeline, marketed products and other business interests. 
• Ensures proactive management of regulatory requirements from all aspects of the business. 
• Manages overall workflow across Regulatory Affairs to ensure proper resource allocation, compliant regulatory activity management within prescribed timelines.
• Works with team members to identify key issues and develop strategies for successful regulatory activities for all Roche Diagnostics South Africa products.
• Ensures internal business partner and stakeholder input is solicited and incorporated into regulatory strategies.
• Determines regulatory activity priorities and the timing for such.
• Oversees and guides regulatory activities according to the regulatory strategy to achieve the best business outcomes for Roche Diagnostics South Africa.
• Reviews activities on a regular basis with other team members and relevant internal business partners and stakeholders.
• Reviews and approves regulatory submissions and circulates for additional internal reviews according to legislative and regulatory requirements and Operating Procedures (SOPs).
• Oversees timely submission of final regulatory applications to health authorities in South Africa and the SADC region.
• Ensure that regulatory activities across the product areas are consistently completed and executed in full compliance with Roche SOPs, legislative and regulatory requirements.
• Ensures reference standards and GMP clearances are obtained in a timely manner.
• Manages import/export licensing requirements.
• Ensures current regulatory certifications, licenses and other permits are in place.

Effectively collaborates and communicates cross-functionally

• Drives best practices and innovations across regulatory strategies and activities.
• Ensures all work instructions and other regulatory information are current and accurate.
• Updates Regulatory Affairs systems with current regulatory activities, timelines and priorities.  Includes electronic and hard copy filings, product information submitted to health authority websites, Roche intranet and internet sites.
• Ensures internal cross-functional teams are provided with current product registration details and other relevant information.
• Ensures appropriate support and assistance for internal/external audits .

Adherence to Roche Corporate principles, policies and practices

• Adheres to Safety Reporting obligations to ensure that Roche is compliant with regulatory obligations at all times.
• Maintain awareness of the company’s requirements for reporting adverse events and other Reportable Safety information.  Reports all relevant events to Drug Safety (Pharmacovigilance/ Metereovigilance) immediately. 
• Maintain awareness of the activities, initiatives and projects specific to role that requires review and/or approval by Drug Safety.
• Ensure review and/or approval by Pharmacovigilance department at SAHPRA etc. is obtained in a proactive and timely manner.
• Complies with all Roche Corporate Business principles, policies and Practices.

Promotional Activity Monitoring

• Review of promotional activities by assessing in line with regulatory requirements, identifying areas of non-compliance, providing feedback and approving when required.
• Support the marketing team on promotional activities by training them on the regulatory requirements and guidelines when required.

Oversight and management of site records management

• Act as the Roche Diagnostics South Africa Records Management coordinator. Oversight and responsibility for efficient and compliant local records management for Roche Diagnostics South Africa.
• Local records management in accordance with directives required by Roche Corporate Records Management Program.
• Creates and implements a retention schedule to support efficient and compliant local records management.
• Ensures effective operation and compliance of Roche Diagnostics South Africa’s Quality System for lifecycle management of procedural documents.

Provides effective back-up for Roche Diagnostics South Africa’s Quality Manager

• Provides effective back-up for the Quality Manager
• Assists Quality Manager with issues management
• Acts as an initial point-of-contact for Quality with authorities
• Acts as part of the Roche Diagnostics South Africa’s Recall Committee

Develops high-quality, effective and efficient policies, procedures, standards, and practices and ensures associated training and knowledge awareness is timely, thorough and targeted

• Helps prepare the Regulatory Affairs department to achieve consistently compliant operations
• Provide expertise in the development of Regulatory Affairs Policies Standard Operating Procedures (SOPs), work instructions and related documentation to assure compliant practices
• Drives ongoing assessment and improvement of current practices
• Where applicable, organises and manages work teams to support development, implementation and ongoing management of new or otherwise improved practices
• Helps ensure Regulatory Affairs systems and procedures are common and harmonised where possible and appropriate
• Develops and maintains Regulatory Affairs training grid
• Coordinates, rolls out and maintains procedural document training activities and training compliance for Regulatory Affairs 

You, as an ideal candidate, will have the following skills, experience and education:

• Required Qualification: NQF 7 degree in pharmacy or other life sciences
• Required Experience:  At least 4 years regulatory experience in the pharmaceutical, biotechnology, or related industry. Significant experience working with health authorities and relevant governmental departments is required as well as expert knowledge of Post Market Surveillance, GMP, Industry Codes of Conduct and other relevant standards and guidelines. Advanced skill levels of the Microsoft Office suite (Word, Excel and Powerpoint) are required.