Regulatory Affairs Consultant

Apsida Life Science; Melbourne; Hybrid; AUD 156,000 - 234,000; Full time

Job summary

Apsida Life Science is seeking a Regulatory Affairs Consultant for biologics in Melbourne. This hybrid, 12+ month contract focuses on developing regulatory strategies and serving as the primary liaison with the TGA to support Australian submissions.

You will manage CTD submissions, lifecycle activities, and regulatory intelligence while collaborating with global teams to ensure successful registrations and variations.

Qualifications

• 5–10 years of regulatory affairs experience in pharma/biotech.
• Hands-on experience with TGA interactions and Australian submissions.
• Experience with biologics, plasma-derived therapies, IG products.
• Experience with CTD dossier preparation.
• Ability to work independently and coordinate cross-functional teams.

Responsibilities

• Develop and execute regulatory strategies for biologic products within the Australian market.
• Act as a key regulatory contact and liaison with the Therapeutic Goods Administration (TGA).
• Manage regulatory interactions, including pre-submission meetings, responses to deficiency questions and regulatory negotiations.
• Prepare, review and support CTD submissions in accordance with TGA requirements.
• Provide regulatory guidance for biologics, including plasma-derived products and Immunoglobulin (IG) therapies.
• Manage product lifecycle activities, including registrations, variations, renewals and line extensions.
• Review regulatory documentation covering quality (CMC), clinical, non-clinical, labelling and Risk Management Plan (RMP) requirements.
• Monitor Australian regulatory developments and provide regulatory intelligence to relevant stakeholders.
• Collaborate with global Regulatory Affairs, Quality, Clinical, Manufacturing and cross-functional teams to support regulatory activities.

Skills

Regulatory strategy

TGA liaison

CTD submissions

Biologics experience

Stakeholder management

Education

Bachelor's degree in Life Sciences

Tools

CTD software familiarity

Job description

Job title: Regulatory Affairs Consultant - Biologics

Location: Melbourne, Australia

Work Arrangement: Hybrid

Contract Duration: 12+ months

Working Hours: 155–160 hours/month

Company Overview

Apsida Life Science is partnering with a leading global Contract Research Organisation (CRO) specialising in clinical development, regulatory affairs, and consulting services for the pharmaceutical, biotechnology, and medical device industries. The organisation supports life sciences companies worldwide throughout the product development lifecycle, from early-stage research and clinical trials through to regulatory approval and commercialisation.

Key Responsibilities

• Develop and execute regulatory strategies for biologic products within the Australian market.
• Act as a key regulatory contact and liaison with the Therapeutic Goods Administration (TGA).
• Manage regulatory interactions, including pre-submission meetings, responses to deficiency questions and regulatory negotiations.
• Prepare, review and support Common Technical Document (CTD) submissions in accordance with TGA requirements.
• Provide regulatory guidance for biologics, including plasma-derived products and Immunoglobulin (IG) therapies.
• Manage product lifecycle activities, including registrations, variations, renewals and line extensions.
• Review regulatory documentation covering quality (CMC), clinical, non-clinical, labelling and Risk Management Plan (RMP) requirements.
• Monitor Australian regulatory developments and provide regulatory intelligence to relevant stakeholders.
• Collaborate with global Regulatory Affairs, Quality, Clinical, Manufacturing and cross-functional teams to support regulatory activities.

Required Experience

• 5 - 10 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Strong hands‑on experience interacting with the Therapeutic Goods Administration (TGA).
• Experience supporting regulatory activities for biologic products.
• Understanding of Australian regulatory requirements and submission procedures.
• Experience with product registrations, regulatory submissions and lifecycle management.
• Knowledge of CTD dossier preparation and review.
• Strong regulatory documentation, technical writing and stakeholder management skills.
• Ability to work independently and manage operational regulatory activities.
• Experience with Immunoglobulin (IG) products and plasma-derived therapies.
• Exposure to other complex biologics or advanced therapies.
• Knowledge of Australian orphan drug and priority review pathways.
• Experience working with global regulatory teams and local affiliates.