ProductLife Regulatory Affairs Officer Hiring

ProductLife Group Regulatory Affairs Officer (AU/NZ) | Remote Pharma Job

ProductLife Group is hiring experienced professionals for the role of Regulatory Affairs Officer (AU/NZ). This is a remote, full-time opportunity for candidates with strong expertise in pharmaceutical regulatory affairs, especially within Australia and New Zealand markets. The role focuses on supporting global regulatory submissions, compliance, and lifecycle management activities across pharmaceuticals, biologics, and medical devices.

This position is ideal for professionals with at least 3 years of experience in regulatory affairs who are looking to work in a global consulting environment with exposure to international regulatory frameworks.

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Company Overview

ProductLife Group is a globally recognized consulting firm specializing in regulatory affairs, pharmacovigilance, quality compliance, and market access services for the life sciences industry. The company partners with pharmaceutical, biotechnology, and medical device organizations to ensure regulatory compliance and accelerate product approvals across global markets.

With a strong presence across Europe, Asia-Pacific, and North America, ProductLife Group is known for its scientific expertise, regulatory intelligence, and high-quality consulting services. The organization plays a critical role in supporting healthcare innovation by ensuring safe and compliant delivery of medicines and medical technologies.

Working at ProductLife Group offers exposure to global regulatory agencies, complex submission processes, and cross-functional project management in a highly collaborative environment.

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Job Role & Responsibilities

As a Regulatory Affairs Officer (AU/NZ), you will support regulatory activities related to Australia, New Zealand, and JAPAC regions. The role involves handling submissions, lifecycle management, and compliance documentation.

Key Responsibilities:

• Support registration and listing of pharmaceuticals, biologics, and medical devices in Australia and New Zealand
• Manage maintenance of existing product registrations and regulatory lifecycle activities
• Provide eCTD publishing support for regulatory submissions
• Prepare, review, and submit regulatory dossiers to TGA and Medsafe
• Assist in responding to regulatory queries from TGA and Medsafe authorities
• Support preparation of complex regulatory applications under senior guidance
• Contribute to project management and client coordination activities
• Prepare and manage GMP clearance applications for regulatory submissions
• Develop, review, and update quality and compliance documentation

This role directly contributes to ensuring regulatory compliance and timely market access of healthcare products, making it critical in the pharmaceutical product lifecycle.

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Eligibility / Qualifications

Educational Qualification:

Undergraduate degree in Pharmaceutical Sciences or any relevant scientific discipline

Eligible backgrounds include:

B.Pharm, M.Pharm, B.Sc, M.Sc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Pharmaceutics, Pharmacology, Regulatory Affairs, Clinical Research

Experience:

• Minimum 3 years of experience in regulatory affairs
• Preference for candidates with Australia and New Zealand regulatory experience
• Experience in a commercial or consulting environment is preferred

Required Skills:

• Strong knowledge of TGA and Medsafe regulations, guidelines, and submission processes
• Experience with eCTD publishing and regulatory dossier preparation
• Good understanding of GMP clearance processes
• Strong project management and problem-solving skills
• High attention to detail and ability to manage confidential data
• Excellent written and verbal communication skills
• Ability to work under deadlines in a fast-paced regulatory environment
• Proficiency in basic computer applications and documentation tools

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Location & Salary

• Job Location: Remote (India)
• Job Type: Full-time
• Salary: Competitive salary package based on experience and industry standards

This remote regulatory affairs role provides flexibility while working on high-impact global pharmaceutical projects.

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Application Process

Candidates can apply directly through the official job link below:

Apply Here: https://www.linkedin.com/jobs/view/4396578546/

Ensure your resume highlights relevant regulatory experience, especially related to TGA, Medsafe, and international submissions.

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Why Join ProductLife Group?

• Work with a globally recognized regulatory consulting firm
• Exposure to international regulatory frameworks (TGA, Medsafe, global agencies)
• Opportunity to work on pharmaceuticals, biologics, and medical devices
• Strong learning and development environment
• Career growth in regulatory affairs, compliance, and consulting
• Remote work flexibility with global project exposure

This role is highly suitable for professionals aiming to advance their careers in global regulatory affairs and pharmaceutical consulting.

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Frequently Asked Questions (FAQs)

1. What is the required experience for this role?

Candidates must have a minimum of 3 years of experience in regulatory affairs.

2. Is Australia and New Zealand experience mandatory?

It is not mandatory but highly preferred, especially experience with TGA and Medsafe submissions.

3. Is this a remote job?

Yes, this is a full-time remote role based in India.

4. What qualifications are required?

A degree in pharmaceutical sciences or a related life sciences field is required.

5. What type of work will I be doing?

You will handle regulatory submissions, dossier preparation, compliance documentation, and lifecycle management activities.

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Summary Table

Category	Details
Company	ProductLife Group
Vacancies	Regulatory Affairs Officer
Required Education	B.Pharm, M.Pharm, B.Sc, M.Sc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Pharmaceutics, Pharmacology, Regulatory Affairs, Clinical Research
Experience	Minimum 3 Years in Regulatory Affairs (AU/NZ Preferred)