Permanent - Senior Regulatory Affairs Manager - Johannesburg (Incl. Northern Suburbs) - South Africa

Reporting to Head: Regulatory Affairs

Job purpose:

• Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.
• To ensure legal and regulatory compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications

Qualifications/Experience

• Bachelor’s Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
• Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines
• Demonstrable experience across the product development, commercialization and maintenance lifecycle
• Sound project management capabilities
• Proven ability to consistently deliver to quality, time and cost standard

Key Job Outputs

• Manage work streams for- and report on the assigned group of portfolios
• Assisting with internal product queries from relevant departments
• Assisting with external product queries from the company, other MRA’s and third-party stakeholders
• Establish regulatory priorities and allocate resources and workloads
• Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
• Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
• Develop regulatory strategies and implementation plans for the preparation and submission of new products
• Conduct dossier due diligence to ensure all data gaps are addressed
• Prepare the registration applications for submission to the regulatory authorities
• Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
• Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
• Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Internal training and mentoring
• Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
• Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Manage activities such as internal audits or regulatory agency inspections
• Ensure alignment of personal and company values

Core competencies

• Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
• IT skills
• Leadership skills
• Management of personnel resources
• Ability to prioritise and work to tight deadlines
• Systems and operations analysis
• Basic cost management skills
• Active learning
• Strategic thinking
• Ability to cope with a high degree of complexity and change
• Cross Functional skills: Ability to network, liaise and negotiate with others
• Ability to set standards and objectives and monitor progress
• Complex problem solving and decision-making skills
• Customer relationships
• Development of people
• Must demonstrate responsibility, excellence and collaboration and align with Company value