Site Regulatory Liaison

Overview

Sets up the roadmap to ensure regulatory requirements are met for site manufacturing regulatory approval. Articulates the company expectations of the various regulatory bodies and to ensure that the regulatory body expectations are enforced to the relevant departments. Sets up a professional working relationship with strategic Regulatory Authorities and affiliates with the aim of securing on time regulatory site approvals for local and international markets to secure commercialization of strategic products on Aspen PE site.

Responsibilities

Business and Financial

• Understanding of site strategic financial objectives associated with strategic projects and managing interface from a manufacturing Regulatory approval point of view
• Managing risk associated with delayed Regulatory approval. The risk of commercialization delays are excessive interest payable per day, assets (equipment) remaining idle (i.e. non-commercial state) and loss of sales

Customer and Stakeholder Accountabilities

• Internal: Projects (To obtain product timelines for product submission and commercialisation in order to schedule audits, inclusive of GTP, QA.
• External: Aspen affiliates and AGI (Mauritius) to obtain information for markets and territories (required to adequately plan inspections)
• Engaging with external consultants – e.g. Lachman for US market
• National and Key Regulators or affiliates (EU, FDA, ANVISA, CHINA, JAPAN) – Inspection dates, plans and strategies

Operational Process

• Create, implement and maintain the site regulatory matrix on a regular basis
• Set up and lead professional working relationships with key Regulatory Authorities (e.g. EU, USA, China, Japan, Brazil) including SAHPRA.
• Manage site GMP inspections with a clear link to product submission and commercialization timelines
• Ensuring market regulatory and GMP requirements are met in preparation of onsite inspection or site certification.
• Establish a transparent and defined working relationship with Aspen Affiliates and AGI to align all activities for product submissions

People and Leadership

• Preventing business credibility risk, as a result of: poor interface with Regulators, poor GMP inspection planning or inadequate communication with Regulators
• Promote diversity, equal opportunity and fair treatment in the workplace.
• Promoting Aspen Values
• Enforcing Performance Management Way

Health, Safety And Environmental Standards

• Execute any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
• Ensure that all employees are informed of their scope of authority as contemplated in the OHS Act
• Take full responsibility and necessary measures to ensure that the requirements of the OHS Act are complied with by every person in your employment or on premises under your control where plant and machinery are produced
• Ensure that reasonably practicable steps are taken to identify, manage, eliminate or mitigate any hazard or potential hazards to the safety or health of employees, attached to any work performed, any article or substance produced, processed, used, handled, stored or transported and any plant, machinery which is stored or transported
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

GMP

• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
• Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities

Skills Required

Background/experience

• Bachelor in Pharmacy
• Registration with South African Pharmacy Council (SAPC)
• Computer Literate – MS Word & Excel
• 6 – 10 years’ experience in the Pharmaceutical Industry
• In depth understanding and first-hand experience with regulatory approval processes
• Detailed knowledge of the regulatory lifecycle for both product and manufacturing sites
• In depth understanding of operational systems and interconnectedness
• Knowledge of regulatory authorities GMP requirements
• Experience with Quality Audits process and procedures

Specific job skills

• Good stakeholder management and influencing leaders
• Strong interpersonal and communication skills
• Strong working knowledge of pharmaceutical manufacturing
• Sound knowledge of Good Manufacturing Practice
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Good Documentation Practices

Competencies

• Sense of urgency
• Good communication skills
• Effective problem solving skills
• Organised and effective planning
• Sense of urgency
• Provide tactical proposals to support strategic decisions
• Interrogating Information
• Managing Performance
• Planning and Organising
• Finalising Outputs