Associate Director, Regulatory Affairs

2 weeks ago

Centurion, South Africa FHI Clinical Inc Full time

**Essential Functions**:

- Expected to be the accountable point of contact for designated clients, responsible not only for RA deliverables but also for proactive communication and budget adherence.
- Act as the Lead Regulatory Professional for regulatory projects awarded to FHIC, with support from other senior colleagues.
- Provides Clinical Research Regulatory expertise, input and leadership to cross-functional project teams for assigned products and indications.
- Directs activities related to hiring, training, professional development, managing workload, performance management, salary review, and employee counseling and separations.
- Develop goals and key performance indicators (KPIs) for the Regulatory Affairs Department.
- Meeting and/or communicating regularly with the Global Head, Regulatory Affairs and other key stakeholders for:

- General updates on FHIC activities;
- Updates on changes to relevant national and international legislation and guidelines.
- Updates to changes within the Company and to FHIC Procedural Documents.
- Planning resources for awarded, potential and re-allocated projects.
- Ensure that adequate, appropriately trained personnel resources are available to perform contracted projects to the highest possible standard.
- Monitoring adherence to company policies and procedural documents.
- Collaborating with peers to ensure consistency of management practices.
- Ensuring activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations (labor law) and general duty of care.
- Manage and provide study-specific quality oversight reports, work allocation, FTEs, metrics, KPIs and other required reports to management
- Ensure compliance to KPIs through active engagement with Project Teams, Functional Team leads and external personnel to identify gaps and develop strategies to meet KPIs.
- Identify study-specific compliance gaps and track resolutions to closure quickly. Escalate issues and/or process improvement suggestions and collaborate cross-functionally to define and implement solutions,
- Development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, and tools.
- Develops and maintains strong business relationships with sponsors and clients.
- Ensures that clinical projects are conducted in compliance with all relevant regulations and guidelines.
- Prepare, review and track operating budgets for RA activities as required for proposals and bid defenses, either as a primary project management function (for RA-only awards), jointly with FHIC’s designated Project Manager (for multi-service awards)
- Structure, maintain and regularly update FHIC’s current database of information on all applicable laws, regulations and guidelines pertaining to relevant Health Authorities and Ethics Committees (including SOPs, contact information, member lists, and website links); and track published drafts and/or final legislation for opportunity to provide comment prior to promulgation.
- Support Client Solutions activities by preparing concise fact sheets on various regulatory processes for potential clients and provide RA input into proposals and bid defense activities and present at bid defenses.
- Identify and prepare solutions to regulatory challenges that facilitate TCD achievement of client goals.
- Ensure compliance with regulatory processes, in readiness for internal and external audits/inspections.
- Review, interpret and provide training on new regulations or guidelines, and ensure their integration into FHIC’s quality system.
- If applicable and in accordance with assigned trial-specific tasks and responsibilities, function as the primary point of contact for pharmacovigilance.
- Ensure serious adverse events and safety reports are submitted to the Regulatory Authorities and Ethics Committees within stipulated requirements.
- Suggest, plan, prepare and deliver workshops on Regulatory Affairs topics as appropriate.
- Manage and coordinate regulatory affairs staff to align with departmental, and strategic goals of the Company aimed at improving the quality at FHI Clinical service delivery.
- All other duties as assigned.

**Knowledge, Skills, and Abilities**:

- Proven ability to lead a team and to work as a team member in a cross-functional project team.
- Exhibits an open and constructive leadership style with the knowledge to escalate issues that require supervisory input.
- Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
- High degree of accuracy and attention to detail.
- Well-developed oral and written communication skills and able to communicate in English, effectively and accurately
- Excellent presentation skills.
- Excellent judgment and decision-making skills with a solution orientated approach and a strong sense of urgency.
- Uncompromising at

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