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Job Overview

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
• Hybrid opportunity for a RSUS based in Gauteng with proven experience in clinical start up within a CRO and not site.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.

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About the Opportunity

• IQVIA's client, a leading healthcare and pharmaceutical organisation, is seeking an experienced Regulatory Affairs Specialist to join their Regulatory team on a 12-month fixed-term contract based in Johannesburg.
• This role will be responsible for managing regulatory activities across South Africa and selected Sub-Saharan African markets, ensuring compliance with applicable regulatory requirements while supporting product registrations, lifecycle management, and regulatory compliance initiatives.

Key Responsibilities

• Manage product portfolios of registered products and products under review.
• Compile and submit regulatory dossiers, including new product registrations, variations, renewals, and maintenance submissions.
• Support New Chemical Entity (NCE), CTD, and electronic submissions.
• Liaise with regulatory authorities and respond to regulatory queries.
• Maintain regulatory licenses and ensure timely renewals.
• Create and approve product artwork and labelling materials.
• Ensure compliance with applicable regulations governing medicines, packaging, advertising, and promotion.
• Monitor and communicate relevant regulatory intelligence and changes in legislation.
• Support quality and compliance activities, including audits and SOP implementation.
• Provide regulatory guidance and training to internal stakeholders where required.

Minimum Requirements

• BPharm degree.
• Registered with the South African Pharmacy Council (SAPC).
• Minimum 3 years' experience in pharmaceutical regulatory affairs.
• Proven experience with product registrations, variations, renewals, and dossier maintenance.

Working knowledge of:

• eCTD
• DocuBridge
• SAHPRA Engagement Portal
• FTP
• Veeva Vault
• Strong understanding of regulatory requirements for pharmaceuticals and lifecycle management.
• Excellent communication, stakeholder management, and project management skills.
• Strong attention to detail and ability to manage multiple priorities.

Preferred Experience

• Experience working across South Africa and other Sub-Saharan African markets.
• Knowledge of quality management systems and pharmaceutical compliance requirements.
• Experience engaging directly with regulatory authorities.

What We're Looking For

• The successful candidate will be a proactive, detail-oriented regulatory professional with strong technical expertise and the ability to work effectively across cross-functional teams. You will thrive in a fast-paced environment and be passionate about ensuring regulatory compliance while enabling successful product commercialisation.

Important Information

• This is a 12-month fixed-term contract position based in Johannesburg, South Africa.

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• We are looking for a CPM Line Manager to join our cFSP team and provide leadership, coaching, and functional oversight to an assigned group of Clinical Project Managers.
• This opportunity could suit an established people manager, but previous formal line management experience is not essential for the right candidate. We are also keen to hear from high-performing Senior or Lead Clinical Project Managers who have demonstrated leadership through mentoring, coaching, study team oversight, stakeholder management, or similar responsibilities and are ready to take the next step in their career.
• The successful candidate will combine a strong clinical project management background with excellent communication and stakeholder management skills, a collaborative leadership style, and a genuine passion for developing people.
• Experience leading global clinical studies within a sponsor-dedicated/FSP model, CRO, or large pharmaceutical environment will be particularly relevant to this opportunity.

What you will be doing

• As a CPM Line Manager, you will provide dedicated line management, leadership, coaching, and functional oversight to an assigned team of Clinical Project Managers within the cFSP model.

Your responsibilities will include:

• Conducting regular 1:1 meetings with direct reports, providing coaching, performance feedback, career development support, and oversight of project responsibilities.
• Setting clear performance expectations and objectives and supporting ongoing performance management.
• Coaching and mentoring team members to support their professional growth, leadership development, and longer-term career progression.
• Leading the onboarding, training, and integration of newly hired CPMs into the cFSP model.
• Completing and reviewing competency assessments and individual development plans with direct reports.
• Monitoring team performance, engagement, workload, training completion, and development needs.
• Supporting employee engagement initiatives and contributing to action planning based on employee feedback.
• Ensuring CPMs understand their responsibilities within the client-led work package and product delivery model, including appropriate communication, escalation, and adherence to required standards.
• Ensuring work is conducted in accordance with applicable processes, policies, procedures, quality standards, SOPs, and regulatory requirements.
• Reviewing resource allocation and workload across the CPM team and partnering with leadership on capacity planning, succession planning, and backfill activities.
• Producing and presenting team status reports, resource summaries, and operational updates for functional and senior leadership.
• Supporting direct reports with expectations relating to resource management, time reporting, compliance, training, and operational discipline.
• Partnering with functional leadership, client stakeholders, and operational teams to support effective resource management and clear ways of working.
• Driving continuous improvement activities and encouraging the sharing of best practices across the CPM team.
• Representing the CPM line management function during internal meetings, governance discussions, talent reviews, and client-facing forums as required.
• Supporting recruitment, interviewing, onboarding, and workforce planning activities for the CPM function.
• Serving as an escalation point for team members and providing guidance on people-related, operational, and resource management challenges.
• Promoting a culture of accountability, collaboration, inclusion, engagement, and continuous development across the team.
• Participating in functional, organizational, and client-driven initiatives supporting talent development, resource management, and strategic business objectives.

What we are looking for

• We are looking for someone with strong clinical project management experience who can demonstrate both successful project delivery and the ability to lead, influence, and develop others.

You will ideally bring:

• A Bachelor's degree in life sciences or a related field, or an equivalent combination of education, training, and relevant experience.
• At least 5 years of clinical research experience, including minimum 3 years of leadership experience.
• Strong clinical project management experience, ideally including responsibility for global studies.
• Experience within a sponsor-dedicated/FSP model, CRO, or large pharmaceutical environment.
• Previous formal people management experience is valuable, but not essential. Leadership experience gained through mentoring, coaching, study team oversight, or similar responsibilities will also be considered.
• A strong understanding of clinical trial conduct and applicable clinical research regulatory requirements, including ICH-GCP and relevant local regulations and guidelines.
• A proven ability to deliver projects successfully against quality and timeline expectations.
• Strong stakeholder engagement and relationship management skills, including the ability to work effectively with clients, colleagues, and senior stakeholders.
• Excellent communication and interpersonal skills.
• Strong coaching, influencing, negotiation, judgment, and decision-making capabilities.
• Good problem-solving skills and the ability to proactively identify and address performance or operational challenges.
• The ability to establish effective working relationships across functions and geographies, with awareness and understanding of cultural differences.
• A collaborative and inclusive leadership style with a genuine interest in supporting the development and success of others.
• Strong organizational and computer skills, including MS Office applications.