Job Purpose
As a Regulatory Conformance Specialist you will develop and provide input to regulatory strategies, change control and compliance issues for the manufacture and registration of established API (Active Pharmaceutical Ingredients), Finished Products and New Product Introductions (NPIs). The role ensures site compliance by interpreting corporate standards (e.g. the QMS), pharmacopoeial requirements, regulatory authority directives, license renewals/annual reports and commitments made to regulatory authorities. You will support the Quality Assurance department and all manufacturing units across the site by handling compliance to all licences in all markets supplied (directly or via a packaging site).
Key Responsibilities
Act as product regulatory specialist for the site:
Provide product regulatory advice for the impact of all changes made on site ensuring regulatory compliance in all markets.
Maintain product quality specifications to ensure manufacturing and release and end of life testing complies with registered details and pharmacopoeial requirements.
Provide and approve regulatory information for periodic product reviews.
Lead NPI submissions and reviews working with site SMEs and central/local functions to meet GSK submission & launch dates and without undue regulatory restriction on company operations. Ensure robust evaluation of registered detail that will be submitted to allow future operational flexibility and ensure compliance.
Act as the primary site contact with central regulatory groups (pre and post‐approval) and Local Operating Companies (LOCs), making decisions on behalf of the site:




Develop regulatory strategies using innovative thinking to support site and business strategies/priorities (NPI & existing products – line extensions), approving plans for wave 3 launches.
Review and approve all regulatory documents (submissions, variation dossiers, licence renewals, response to questions and annual reports) to meet GSK submission & launch dates and without undue regulatory restriction on company operations.
Support regulatory compliance on site:
Internal and external audits.
Regulatory/Pharmacopoeial Intelligence.
Provide support to maintain statutory Site licenses.
Lead or assist with quality and compliance‐related deviations.
About You
As this role is multi‐faceted and includes liaising with a wide variety of on‐site production and operations teams, you will be a self‐motivated person who has experience of working in regulatory, quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with robust people skills. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.
Basic Qualifications
Relevant qualifications (e.g.



HND or 'A' levels in scientific, technical engineering discipline) and/or equivalent experience (ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).
Experience of managing regulatory compliance or regulatory affair‐processes related activities within a pharma or consumer supply chain environment.
Knowledge of current Good Manufacturing Practice (cGMP) requirements.
Experience obtained working in highly regulated industry, including knowledge and application of the principle of the Quality Management Systems (QMS).
Preferred Qualifications
Experience in regulatory affairs, particularly post‐approval licence maintenance and variation submissions, would be preferred but is not compulsory.
Benefits
Competitive base salary.
Annual bonus based on company performance.
Opportunities to partake in on‐the‐job training courses.
Opportunities to attend and partake in industry conferences.
Opportunities for support for career development/chartership.
Access to healthcare and wellbeing programmes.
Employee recognition programmes.
Equal Opportunity Employer
GSK is an Equal Prospect Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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📌 Regulatory Conformance Specialist (Western Australia)
🏢 Gsk
📍 Western Australia