Position Summary:

The Vice President, Regulatory Affairs will be responsible for the development and execution of the company’s Regulatory strategy and report into the Senior Vice President, Regulatory and Quality.  This critical hire will provide input, prioritize, implement, monitor, and communicate Vera’s Regulatory strategy and programs.  As part of the Quality and Regulatory leadership team, you will establish and translate Vera’s Regulatory strategy into operational policies, processes, procedures, and training to meet global regulatory, medical/health, and legislative standards.  This role requires experience, knowledge, and leadership credibility to be effective across Vera in multiple capacities, thereby ensuring compliance with Regulatory standards and corporate-wide commitment to Quality principles and Vera values.

Responsibilities:

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• In this highly visible role, the successful candidate will develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals.
• Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions.
• Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations.
• Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre-submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
• Partner closely with cross-functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration.
• Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements.
• Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments.
• Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions.
• Establish and continuously improve phase‑appropriate regulatory processes, standards, and governance (e.g., submission planning, HA interaction tracking, labeling governance) suitable for a lean organization.
• Stay current on evolving global regulatory requirements, guidance, and precedent, and proactively incorporate learnings into program strategies and company policies.
• Support business development activities by contributing regulatory due diligence, risk/benefit assessments, and integration planning for potential partnerships, in‑licensing, and acquisitions.
• Represent Regulatory Affairs on cross‑functional governance bodies and, as needed, with partners, and external stakeholders.

Qualifications:

• Advanced degree in life sciences or related discipline (e.g., PhD, PharmD, MD, or MS); equivalent experience may be considered.
• 15+ years of increasing responsibility in biopharmaceutical regulatory affairs, including substantial experience in small or mid‑size biotech environments.
• Proven track record of leading major global submissions (IND/CTA and NDA/BLA/MAA or equivalent) through acceptance and, ideally, approval.
• Demonstrated experience interacting directly with FDA, EMA and other global health authorities, including leading meetings and negotiations on complex issues.
• Strong understanding of global regulatory frameworks (ICH, FDA, EMA and other regional requirements) across early development, registration, and post‑approval lifecycle management.
• Experience overseeing or partnering with CMC, regulatory operations/electronic submissions (eCTD), and safety/periodic reporting activities.
• Demonstrated ability to build, lead, and develop teams, and to work effectively as both a hands‑on individual contributor and strategic leader in a lean, fast‑paced biotech setting.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to both technical and non‑technical audiences, including senior leadership and external partners.
• High degree of integrity, sound judgment, and a pragmatic, solutions‑oriented mindset with strong organizational and project management skills.

About us

Woolpert is a global leader in Architecture, Engineering, and Geospatial (AEG), with a deep rooted and growing presence across Australia, building on our rich heritage as AAM. We are recognised as a Top 100 Global Design and Geospatial firm, Woolpert delivers leading-edge solutions in aerial mapping, surveying, and digital solutions for some of Asia-Pacific’s largest resources, infrastructure and environmental projects.

The ’Woolpack’ fosters a culture of innovation, inclusion, and ownership – exemplified by our celebrated Principal Program, which offers all employees, regardless of role or employment type, the opportunity to become company owners and share in the company’s growing success. This program rewards leadership, high performance, and initiative, and is a cornerstone of Woolpert’s commitment to empowering its people and expanding diverse leadership.

Great Place to Work®!

We’re proud to be certified as a Great Place to Work® for the 9th time! We invest in advanced tools and professional development to empower our teams. Built on trust, respect, and shared success, our culture makes Woolpert more than a workplace – it’s a community.

The opportunity with us as a Regional Marketing Manager

We are looking for a Regional Marketing Manager to join our high performing team. Reporting to the Senior Marketing Manager, Asia-Pacific you will be the voice of the region, translating global marketing strategy into regional marketing impact driving pipelines, revenue growth and brand consistency. This is a full time permanent position with hybrid work arrangements. You may choose to be based in our Brisbane or Sydney office.

You will be:

• Acting as the voice of the region by bringing forward market dynamics, customer needs, and regional business priorities to inform global marketing strategy.
• Translating global marketing strategy into regional activation plans that drive business growth.
• Developing and executing regional go-to-market plans aligned with industry priorities and commercial growth objectives.
• Owning regional demand generation and execution across campaigns, events, webinars and partner programs.
• Partnering and supporting Sales, Communications and Digital Marketing teams to ensure brand consistency and alignment with the local market.
• Tracking, reporting and optimising regional marketing performance across pipeline contribution and campaign and events ROI, as well as lead generation and engagement metrics.

We’re looking for someone who has:

• Tertiary Marketing qualifications or equivalent, and at least four years of relevant experience.
• Experience in strategic marketing planning and regional GTM execution.
• Strong commercial mindset with an understanding of pipeline development and sales alignment.
• Expertise in demand generation and campaign strategy.
• Flexibility and adaptability and willingness to travel up to 25% as required.
• Excellent stakeholder engagement and communication skills, with the ability to build and maintain relationships.
• Strong problem-solving skills.

With this role, the successful candidate must successfully pass pre-employment police background . 

Desirable experience:

• Experience working in the geospatial, engineering or professional services industries would be advantageous.
• Experience working with global teams.

#LI-KS2

 #LI-Hybrid

Woolpert Benefits:

• Want to earn long-term rewards that reflect your impact? Woolpert’s Principal Program gives employees the opportunity to become stakeholders in the company and benefit directly from its growth and success.
• Want surety for your income? Woolpert employees benefit from automatic Salary Continuance Insurance provided by the company.
• Want to make the most of your salary? Woolpert offers novated leasing and salary sacrifice options to help you get more value from your income.
• Thinking of advancing your studies? Woolpack members wanting to continue their formal education with role related courses have access to reimbursements and study leave options to assist with their studies.
• Need flexibility with where you work? Subject to operational requirements Woolpert offer flexible work arrangements.
• Looking after your wellbeing? Woolpert employees and their immediate family members have access to our confidential Employee Assistance Program, along with our discounted voluntary corporate health insurance through Bupa.

We value diversity and inclusion at Woolpert and are committed to creating a workplace that reflects the diversity of the communities we serve. We welcome applications from First Nations peoples.

As this is a full-time role, this role requires individuals with Full Working Rights in Australia. Only shortlisted candidates will be contacted.

If you believe you might be a good fit and would like to join our Woolpack, click on the APPLY NOW button to submit your application. If you don’t meet all the preferred qualifications for this position, we encourage you to still apply!

Good people. Good work. Great opportunities.

McCullough Robertson is a commercially focused firm with a proud 100 year history, working with high-calibre national and international clients. We work on big matters in small teams, approaching each day with dedication and professionalism.       

We provide exceptional opportunities for our employees to perform, grow and succeed through extensive training and career development. Our teams work together and support one another to achieve individual, team and firm-wide goals.

Backed by a national team of over 400 staff located in Brisbane and Sydney, McCullough Robertson combines a century of experience with a modern, collaborative approach, making us a big firm, without the attitude.

The Role

As we build on the momentum of our centenary year and continue to support the firm’s strategic priorities, we are seeking a Business Development and Marketing Coordinator to join our Brisbane office. You will form part of the national BDM team, contributing to a strong culture of collaboration and high-performance. 

It is a fantastic opportunity for a BD & Marketing Coordinator eager to gain further experience in the legal industry in a firm that prioritises continuous improvement and genuine career development opportunities.  The role is well suited to someone who thrives in a fast-paced environment, enjoys taking ownership, and is motivated to build a career in business development and marketing within a high-performing professional services team.

Your main responsibility will involve supporting the firm’s Business Development Leads in executing practice, industry group and client strategic plans, and your day-to-day will include:

• Delivering high-quality panel and project/matter-specific tenders and credential statements (often working directly with senior lawyers and partners in their respective practice or industry groups);
• End-to-end coordination of firm, practice and client events, ensuring a seamless experience and a high standard of delivery;
• Preparing email marketing campaigns and social media posts, including developing copy in line with the firm’s key messaging, and creating relevant digital assets;
• Contributing to the firm’s strategy, including supporting various projects in involving the firm’s centenary this year, and working on innovation projects to enable data-driven decision-making and task automation;
• Assisting with the ongoing maintenance of our client relationship management (CRM) system (Dynamics 365);
• Participating in client listening initiatives, including tender debriefs;
• Preparing legal directory submissions, coordinating input and ensuring consistency, accuracy and a high-quality final product;
• Managing client and industry research and reporting;
• Assisting with management of the firm’s strategic partnerships and sponsorships;
• Assisting with internal communications, including the preparation of our monthly newsletter, and developing content for our internal social media channel.

Experience

As a successful candidate, you will hold or be working towards tertiary qualifications in a business or communications-related discipline, and have a minimum of two years’ experience as a Business Development and Marketing Assistant/Administrator.

You will be both enthusiastic and proactive, with a keen interest in engaging with a diverse range of tasks and responsibilities. 

Furthermore, you will demonstrate the following attributes:

• Excellent attention to detail;
• Strong writing, verbal communication and presentation skills;
• Strong organisational skills, including the ability to prioritise workflow, follow procedures, and communicate progress effectively;
• Prior experience working with stakeholders at varying levels, with a collaborative and service-orientated approach;
• A hands-on, proactive and collaborative working style;
• Flexibility to undertake a range of tasks while appropriately managing priorities and deadlines;
• An interest in continuous learning and process improvement;
• Sound judgment and professionalism to deal with sensitive and confidential information.

Benefits

At McCullough Robertson, we encourage a balanced work environment. Our teams enjoy having the opportunity to work in a supportive environment while having fun and achieving results.

We offer the following benefits for our employees:

• Dedicated diversity committee with an innovative program focusing on all areas of diversity and inclusion;
• Attractive further education program and supportive learning and development opportunities throughout your whole career;
• Mentoring and sponsorship opportunities as well coaching and leadership support;
• Holistic health and wellbeing program including subsidised gym membership and active social and sporting committees; and
• End-of-trip facilities.

Inclusion and Diversity

We are a leader in diversity and inclusion and are committed to creating an inclusive environment for all employees.

Our commitment is to create an accessible, inclusive and informed workplace, where we can collectively make a difference for everyone, including people with disability, to gain equal opportunities and grow their career at McR. This is our commitment to diversity and inclusion and how we bring to life our McR values.

An award-winning law firm, we have received the prestigious Employer of Choice for Gender Equality citation for the tenth consecutive year and have recently been awarded by Lawyers Weekly – Diversity Law Firm of the Year.

To apply for this position, please click on the "Apply for Job" button, and submit your application online. Alternatively, please contact Sophie Sims on 07 3914 8462 for a confidential discussion.

We're an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

COMPANY OVERVIEW

ThreatLocker® is a leader in endpoint protection technologies, providing enterprise-level cybersecurity tools to improve the security of servers and endpoints. The ThreatLocker® platform with Application Allowlisting, Ringfencing™, Storage Control, Elevation Control, Endpoint Network Control, Configuration Management, and Operational Alert solutions are leading the cybersecurity market toward a more secure approach of blocking the exploits of application vulnerabilities.

JOB OVERVIEW

The successful candidate will play a key role in achieving our customer acquisition and will be part of our rapidly growing sales team with multiple career paths available.

As an Account Executive you are responsible for but not limited to:

• Working with sales leadership to develop a sales plan and target list of accounts to penetrate, leveraging sales intelligence tools as needed
• Using our CRM to build your sales pipeline.
• Focus and commitment to crushing your outbound campaign targets
• Meeting / exceeding weekly and monthly performance targets 
• Outbound with the phone, email, and social media activities to thoughtfully engage potential prospects
• Regularly engage with account execs and sales & marketing leadership to discuss market feedback and learnings in order to refine your elevator pitch and target account lists.

REQUIRED QUALIFICATIONS

• Minimum of two years of outside sales experience; B2B sales preferred
• Experience in software-centric in SDR or BDR positions, preferred
• Proficient in identifying and engaging MSP or MSSP leads and in high volume outbound prospecting
• Experienced in CRM (Salesforce, Sugar, etc.) to build and maintain pipeline
• Effective oral and written communicator
• Startup experience, preferred
• Highly organized and adaptable to a dynamic work environment

WORKING CONDITIONS

The duties described below are representative of those encountered while performing the essential functions of this position. If necessary, reasonable accommodation may be requested and will be evaluated for its relationship to the essential functions that must be performed.

• Job will generally be performed in an office environment but may require travel to visit company offices and/or property locations.
• While performing duties of this job, would occasionally require to stand, walk, sit, reach with hands and arms, climb or balance, stoop or kneel, talk and hear, and use fingers and hands to feel objects and tools.
• Must occasionally lift and/or move up to 15kg.
• Specific vision abilities required include close vision, distance vision, depth perceptions, and the ability to adjust focus.

A background check and drug/substance screening are required after a conditional offer. Employment will proceed only upon receiving clear results from both.

ThreatLocker also conducts randomized drug and substance testing approximately every 60 days, in line with the same screening standards.

Requirements

What's the Opportunity?

We are looking for Product Support Consultants to join our support team to help our customers use Zenoti effectively to run their business.  This will be an in-office position based in our office in Brisbane.

What Will I be doing?

• Receive inbound help requests from customers via the primary channels of phone call, chat, and email.
• Own customer reported issues and see problems through to resolution; be an advocate for our customers and their needs.
• Consult with customers to ensure their business operations run effectively on Zenoti
• Demonstrate the ability to research, document, and prioritize customer issues, leveraging internal tools and escalation teams as necessary, as well as prioritizing and managing time effectively in a fast-paced environment;
• Raise issues to higher levels of support as needed; be able to identify when you need help to solve an issue
• Be a trusted advisor to our customers on issues related to Zenoti products and experience in a way that results in high customer satisfaction;
• Develop and maintain technical expertise in assigned areas of product functionality and utilize that expertise effectively to help customers;
• Provide peer mentorship to team members
• Create knowledge base materials dedicated towards operational efficiency, while also empowering and enabling the greater support community.
• Be proud of what you work on, obsess about the quality of the work you produce.
• Influence the direction of the product by providing feedback about challenges customers have with using our product.

What Skills do I need?

• Minimum 1 year in a public-facing, The ideal candidate will come from an IT, hospitality or retail background
• Experience running a Point-of-Sale or reservations system
• Tenaciousness and perseverance
• A technology-centric background with demonstrated curiosity and self-learning

Why Zenoti?

• Be part of an innovative company that is revolutionizing the wellness and beauty industry. 
• Work with a dynamic and diverse team that values collaboration, creativity, and growth. 
• Opportunity to lead impactful projects and help shape the global success of Zenoti’s platform. 
• Attractive compensation. 
• Regular social activities, and opportunities to give back through social work and community initiatives.