Regulatory Affairs Specialist

6 days ago

Macquarie Park, Australia Indivior Full time

TITLE:
Regulatory Affairs Specialist

Regulatory Affairs Specialist, AustralAsia

Who we are:
Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Position Summary:
The Regulatory Affairs Specialist, AustralAsia (AuA) reports directly to the Head of Regulatory Affairs (Most of World), based in Europe, with a dotted reporting line to the Head of AustralAsia. The position is a stand-alone role within the Australian affiliate.

The Regulatory Affairs Specialist is responsible for ensuring and maintaining regulatory compliance of approved and marketed Indivior products in the AuA region (Australia, New Zealand and Asia) and managing relationships and interactions with the company’s regulators and government agencies.

The responsibilities of this job include, but are not limited to, the following:

- Regulatory Affairs specialist for the Australian sponsor, Indivior Pty Ltd and bears the responsibilities of Indivior Pty Ltd’s regulatory affairs in Australia. In other AuA markets, manages Indivior’s regulatory activities through third party regulatory contractors.
- Ensures the registration and regulatory compliance of locally marketed products.
- Develop regulatory plans; planning, prepare and submit quality regulatory dossiers that meet Regulatory Authority’s requirements; gain timely approvals with optimal indications and label claims in the approved Product Information; and review metrics to track regulatory performance in AuA as driven by local or corporate initiatives.
- Support in obtaining and maintaining all necessary pharmaceutical Marketing Authorization approvals, as well as approvals for Indivior’s products, in compliance with individual health authority and local government regulations.
- Represent Indivior with the TGA, Medsafe and any other AuA regulatory authorities. Build strong relationships with all regulators and maintain effective communication channels with all internal and external stakeholders.
- Engage in discussions with internal stakeholders on the impact of regulation and regulatory change including making recommendations on existing and future strategic directions for AustralAsia.
- Support all activities to update Mock-ups and Commercial Artwork according to SOPs and Working Instructions.
- Provide regulatory support to the Commercial Team to ensure successful product launches and business opportunities to deliver strong business results (e.g., timely artwork development and approvals and timely review of promotional and educational materials).
- Achieve on-time ‘Regulatory Compliance Milestones’ for approved and marketed products to maintain valid product licences, timely licence renewals, and post-approval product maintenance variations, (e.g., CMC; changes to Product Information, labelling & packaging; manufacturing site source add/change); monitoring, interpreting and resolving local regulatory issues; Indivior product Risk Management Plans and other safety reports; and promotional & educational materials in product life-cycle maintenance.
- Develop, maintain, and implement local SOPs to ensure Good Regulatory Practices (GRP) under the ‘Pharmaceutical Quality System’ framework, e.g., robust document management system for filing and archiving; and support internal regulatory self-inspections and internal or external (by third-party organization) regulatory audits.

Who you are:

- Bachelor’s degree in Life Sciences (Pharmacy preferred)
- Minimum of 3-5 years 'hands on' experience in Australia & New Zealand (Regulatory Affairs experience in Asian markets is desirable)
- Working knowledge of regulations and key health authorities in Australia
- Experience in electronic submissions
- Experience in a speciality or niche pharmaceutical business (preferred)
- Experience in controlled substance regulations (advantageous)
- Working knowledge of the Medicines Australia Code of Conduct and Code of Practice

In addition to the minimum qualifications, our new team member will also be able to demonstrate:

- Strong reasoning ability to support and prioritize projects, adapt to shifting priorities, and resolve problems/conflicts. Skilled in research, logic, objectivity, and good judgement, as necessary, to formulate supportable opinions rapidly.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with clinical, pharmacovigilance, supply, quality, legal, sales and marketing, and administration functions.
- Results-oriented, accountable, and self-motivated.
- Strong conceptual, analytical, problem-solving, and organisational skills, and a

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