Regulatory Affairs Director

2 weeks ago

Sydney, New South Wales, Australia Careerlink People Solutions Full time

Head of Global Regulatory Affairs

Careerlink People Solutions is partnering with BiomeBank to present a unique opportunity for a proactive individual with an analytical mindset to join the team as Head of Global Regulatory Affairs.

BiomeBank is a clinical stage biotechnology company with a mission to treat and prevent disease by restoring gut microbial ecology. The company has announced the first regulatory approval for a donor-derived microbiome drug product worldwide.

The Role

Reporting to the Chief Operations Officer, this role is responsible for developing and implementing global (FDA, TGA, EMA) regulatory strategy, filings, product development requirements leading to successful product registration and life-cycle management of unique and technologically complex microbial therapeutics serving patients with unmet medical needs.

You will be responsible for:

  • Developing a clear regulatory strategy to lead all regulatory submissions worldwide
  • Leading a cross-functional team to ensure successful regulatory strategy, drafting, and submission
  • Management of project timelines and budgets, ensuring high-quality delivery to meet company goals
  • Regular reviews of the regulatory landscape regarding live bacterial therapeutics (cultured and donor-derived) for FDA, TGA, EMA as new guidance develops and is published

Requirements

You will bring to this role:

  • Degree in biotechnology, biology, microbiology, or a similar field
  • Experience working with cell therapies
  • Advanced training in regulatory affairs
  • Experience providing strategic regulatory advice in US, AU, EU jurisdictions through all stages of development, including pre-approval and marketed products
  • Experience leading major FDA submissions and FDA meetings
  • Proven track record of successful interactions with FDA/TGA/EMA and practicing sound judgment in relation to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidance, including understanding of GMPs and GCPs, and the ability to obtain key answers when issues are not directly addressed
  • Demonstrated leadership skills with proven ability to manage high volumes of work and competing priorities

What You Will Gain

This role will give you the opportunity to:

  • Take a pivotal role in the growth and development of the BiomeBank team in their expansion
  • Be a crucial leader within a dynamic and multi-cultural team, fostering a great culture and values: Openness, Quality, Innovation, Communication, Solution-oriented

How to Apply

Apply now to be part of a close-knit, passionate, and innovative team at the forefront of microbiome research and working with novel therapies.

  • Regulatory Affairs Director

    4 weeks ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleThis is an exciting opportunity to work with a leading service company for the Pharmaceutical Industry globally. As an Associate Director, Regulatory Affairs, you will be responsible for maximizing client...

  • Senior Regulatory Affairs Director

    2 weeks ago

    Sydney, New South Wales, Australia ENG Con Full time

    We are a leading provider of pharmaceutical regulatory consulting services, and we are seeking an experienced Senior Regulatory Affairs Director to join our team in Sydney, Australia.As a Senior Regulatory Affairs Director, you will play a critical role in ensuring the successful registration and approval of our clients' products in the Australian...

  • Regulatory Affairs Director

    2 months ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleIn this role, you will be responsible for ensuring the regulatory compliance of client products, advising on licensing and marketing strategies, and managing regulatory submissions and approvals.You will...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleIn this role, you will be responsible for ensuring the regulatory compliance of client products, advising on licensing and marketing strategies, and managing regulatory submissions and approvals.You will...

  • Regulatory Affairs Director

    4 weeks ago

    Sydney, New South Wales, Australia ENG Con Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our team in Australia. As an Associate Director, Regulatory Affairs, you will be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.Your Key ResponsibilitiesAdvise and support clients...

  • Regulatory Affairs Director

    2 months ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Summary:ENG Con is seeking an experienced Regulatory Affairs Director to join our Pharmaceutical Regulatory Consulting team in Australia. As a key member of our team, you will be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.Key Responsibilities:Advise and...

  • Regulatory Affairs Director

    9 hours ago

    Sydney, New South Wales, Australia ENG Con Full time

    Company OverviewWe are a leading consulting company, specialized in regulatory affairs for the pharmaceutical industry. Our team of experts has extensive experience in all aspects of drug and medical device approval.SalaryThe estimated salary for this position is AU$140,000 - AU$180,000 per year, depending on experience. We offer a range of flexible working...

  • Strategic Regulatory Affairs Director

    1 week ago

    Sydney, New South Wales, Australia ENG Con Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our Pharmaceutical Regulatory Consulting team in Australia. As a key member of our team, you will be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.Key ResponsibilitiesAdvise and...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Your OpportunityWe are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective is to maximize client commercial success by ensuring...

  • Regulatory Affairs Director

    3 weeks ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Your RoleWe are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective is to maximize client commercial success by ensuring...

  • Regulatory Affairs Expert

    2 months ago

    Sydney, New South Wales, Australia ENG Con Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our team in Australia. As an Associate Director, you will play a key role in maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.Key ResponsibilitiesAdvise and support clients on regulatory...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsOur client, a respected financial institution, is seeking an accomplished professional to join their Regulatory Affairs team. This is an exceptional opportunity to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsOur client, a leading financial institution, is seeking an experienced professional to join their Regulatory Affairs team. This is an exciting opportunity to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior Manager in...

  • Regulatory Affairs Director

    2 weeks ago

    Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsEthos BeathChapman is seeking a seasoned professional to lead their Regulatory Affairs team. This is an exceptional opportunity to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior Manager in Group Regulatory Affairs,...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia Novartis Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novartis. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with local laws, regulations, and company policies.Key ResponsibilitiesDevelop and implement broader regulatory strategies within the team, managing...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia Randstad Full time

    Exciting Career Opportunity in Nutrition Regulatory AffairsWe are seeking a skilled professional to lead our dynamic team dedicated to bringing cutting-edge nutrition products to market.This role offers the opportunity to work at the forefront of nutritional science, influencing products that impact health and wellbeing.Key Responsibilities:Provide...

  • Regulatory Affairs Director

    4 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novartis. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with local laws, regulations, and company policies.Key ResponsibilitiesDevelop and implement broader regulatory strategies within the team, managing...

  • Regulatory Affairs Director

    4 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the RoleAs a key member of our Regulatory Affairs team, you will be responsible for leading a specific portfolio across ANZ. Your primary focus will be on developing regulatory strategies, managing submissions to ensure product approvals, and providing high-level regulatory advice to internal and external stakeholders.Key Responsibilities• Develop...

  • Regulatory Affairs Director

    1 week ago

    Sydney, New South Wales, Australia Careerlink People Solutions Full time

    BiomeBank is a clinical stage biotechnology company with a mission to treat and prevent disease by restoring gut microbial ecology.Careerlink People Solutions are partnering to present an opportunity for a proactive individual with an analytical mindset to join the team as Head of Global Regulatory Affairs.This role is responsible for developing and...

  • Regulatory Affairs Director

    2 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    About the Role:As a Regulatory Affairs Manager at Novartis, you will play a crucial role in managing, planning, and coordinating submissions to health authorities in Australia and New Zealand. Reporting to the Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensuring compliance with all local laws, regulations,...