Biologics Regulatory Affairs Consultant - Hybrid, Melbourne

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

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.