Offer summary

Qualifications:

Minimum of 10 years of experience in regulatory affairs within biotechnology, CRO, or pharmaceutical industry., In-depth understanding of international regulatory requirements, particularly in the USA, Canada, and Europe., Strong experience liaising with overseas regulators such as the FDA and EMA., Excellent written and verbal communication skills with strong analytical and problem-solving abilities..

Key responsibilities:

Develop and implement global regulatory strategies for advancing clinical programs from Phase II to Phase III.

Oversee the preparation and maintenance of Investigational New Drug (IND) documentation to ensure compliance.

Author and review high-quality regulatory submissions including INDs, CTAs, and marketing applications.

Collaborate with internal teams and external consultants to ensure alignment in executing regulatory strategies.

Job description

Clinical Trials
Neurotherapeutics
Biotechnology

The Company

Our client is an ASX-listed biotechnology company developing a novel, best-in-class neuroprotective therapeutic. With an expert team around Australia, they are currently working on a Phase II clinical trial with a view to progressing their lead asset to the next stage of trials and expanding their clinical program globally.

The Opportunity

To advance their clinical program and build upon their team’s internal regulatory capabilities, our client is seeking an experienced Vice President, Regulatory Affairs located in Australia. Supported by the internal team and external consultants, this role will:

Develop and implement comprehensive global regulatory strategies to support the advancement of our clinical programs from Phase II to Phase III and beyond.
Support the development of regulatory strategy and execution of Phase III clinical trials, ensuring compliance with all regulatory requirements and timelines.
Oversee the preparation, updating, and maintenance of Investigational New Drug (IND) documentation, ensuring accuracy and compliance with regulatory standards.
Working with the internal team and external consultants, author and review high-quality regulatory submissions, including briefing documents, INDs, CTAs, and marketing applications (BLAs/MAAs).
Maintain up-to-date knowledge of regulatory requirements and guidelines in key markets, including the United States, Canada, Europe, China, and Japan.
Work closely with clinical, nonclinical, CMC, quality, and other teams to ensure alignment and successful execution of regulatory strategies.

The Requirements

Minimum of 10 years of experience in regulatory affairs within the biotechnology, CRO, or pharmaceutical industry, with a proven track record in coordinating and executing later-stage clinical trials.
In-depth understanding of international regulatory requirements including the USA, Canada and Europe.
Strong experience liaising with overseas regulators including the FDA, EMA, and others.
Excellent written and verbal communication skills, with the ability to effectively interact with regulatory authorities and internal stakeholders.
Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing regulatory challenges as part of a small, dynamic team.

The Offer

The successful candidate will join as a key member of a growing team of experts, supported by external advisors and an experienced board. Position title and remuneration offered are flexible and will reflect experience. Please email any questions you may have to careers@mexec.com or call 1300 063 932 to arrange a time for a confidential discussion with Mark Thomas or Marilyn Jones. To apply, please visit www.mexec.com and click Apply Now to submit your current CV and cover letter.

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