Regulatory Affairs Manager

2 weeks ago

Warriewood, Australia Blackmores Group Full time

As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work practices and family friendly policies

**Purpose**

To lead and manage the regulatory affairs function for listed medicines across Australia and New Zealand, ensuring timely and compliant submissions, approvals, and maintenance of products. This role oversees a team of four regulatory professionals and is responsible for day-to-day operations, strategic planning, and cross-functional collaboration.

This role will manage a team and is expected to work in our Warriewood office at least 4 days a week with 1 day working from home. This role might be open for some flexibility working in either our Warriewood and Surry Hills office.

**Responsibilities include**:
**Regulatory Strategy & Compliance**
- Develop and implement regulatory strategies for listed medicines in ANZ.
- Ensure compliance with TGA and Medsafe regulations, including ongoing monitoring of regulatory changes.
- Oversee preparation, submission, and lifecycle management of regulatory dossiers (e.g., new listings, variations, renewals).

**Team Leadership & Development**
- Manage, mentor, and support a team of four regulatory associates.
- Allocate resources effectively to meet project timelines and business priorities.
- Foster a collaborative and high-performance team culture.

**Operational Excellence**
- Lead day-to-day regulatory operations, ensuring accuracy, timeliness, and quality of submissions.
- Maintain regulatory documentation and systems in accordance with internal SOPs and external requirements.
- Review and approve product labels, advertising, and promotional materials for regulatory compliance.

**Stakeholder Engagement**
- Collaborate with cross-functional teams including Marketing, Quality, Supply Chain, and Medical Affairs.
- Act as the primary contact for regulatory agencies (TGA, Medsafe) for listed medicines.
- Provide regulatory guidance during product development, launch, and post-market phases.

**Continuous Improvement**
- Identify and implement process improvements to enhance regulatory efficiency and compliance.

Stay abreast of industry trends and regulatory developments impacting listed medicines.

**Who are you?**
- Bachelor’s degree in life sciences, pharmacy, or a related field (advanced degree preferred).
- Minimum 5 years of domestic regulatory affairs experience in the pharmaceutical or consumer health industry, with a focus on listed medicines.
- Proven leadership experience managing a team.
- Strong knowledge of ANZ regulatory frameworks and submission processes.Excellent communication, project management, and problem-solving skills.
- Agencies please note: this recruitment assignment is being managed directly by Blackmores Talent Acquisition team. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated._

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