Regulatory Affairs Consultant

Apsida Life Science is partnering with a global Pharmaceutical company to present the following role:

Regulatory Affairs Consutlant

• Location- Australia
• Style- Remote
• Type- 4 month contract role ( with extension)

Position Overview

We are seeking a highly experienced Regulatory Affairs Consultant to support regulatory activities for our Australian affiliate, with a primary focus on biological therapies and complex medicinal products. This role will be responsible for developing and executing regulatory strategies to ensure successful registration, lifecycle management, and continued compliance of biologic products within the Australian market. The consultant will serve as the primary regulatory contact for Australia, working closely with global regulatory teams, cross-functional stakeholders, and external partners to ensure alignment with Therapeutic Goods Administration (TGA) requirements. The role requires deep expertise in biologic product registration, regulatory strategy development, and regulatory intelligence, particularly for specialized therapies such as ImmunoGlobulin (IG) products.

Regulatory Strategy & Agency Interaction

• Serve as the primary liaison with the Therapeutic Goods Administration (TGA), managing regulatory communications, formal submissions, and responses to regulatory queries.
• Develop and implement regulatory strategies for the registration and maintenance of biologic products in the Australian market.
• Lead regulatory interactions including pre-submission meetings, deficiency responses, and negotiation of approval conditions with TGA.
• Ensure alignment of local regulatory strategies with global regulatory objectives and product development plans.

Biologics Regulatory Management

• Oversee regulatory activities for complex biological products, ensuring compliance with Australian regulatory requirements for safety, quality, and efficacy.
• Provide regulatory guidance on biologics-specific regulatory frameworks, including plasma-derived products and advanced therapies.
• Support the preparation and review of Common Technical Document (CTD) modules, ensuring all documentation meets TGA expectations.
• Provide expertise in quality, clinical, and non-clinical regulatory components for biologics submissions.

Product Lifecycle Management

• Manage the full lifecycle of marketing authorizations, including initial registrations, variations, line extensions, and renewals.
• Maintain regulatory compliance for a portfolio of ImmunoGlobulin (IG) and other biologic therapies throughout the product lifecycle.

Regulatory Compliance & Intelligence

• Monitor updates to Australian regulatory legislation, TGA guidelines, and regulatory policies impacting biologic products.
• Conduct regulatory impact assessments and provide strategic recommendations to internal stakeholders.
• Ensure compliance with the Australian Therapeutic Goods Act, including regulatory requirements related to biologics, priority review pathways, and orphan drug designations.

Regulatory Documentation & Technical Writing

• Lead the preparation, compilation, and review of high-quality regulatory documentation, including marketing authorization applications and variation submissions.
• Ensure submissions are scientifically accurate, technically compliant, and aligned with CTD format requirements.
• Review and approve regulatory content including clinical summaries, quality documentation, risk management plans, and labeling documentation.

If you are interested in learning more, please reach out to Mufaro Mpofu at Apsida Life Science:

[email protected]

www.apsida.co.uk.

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.