Associate Director, Regulatory Affairs (IVD)

Precede Biosciences, Inc.; Town Of Cambridge; On-site; AUD 175,000 - 220,000; Full time

Benefits offered by this job

Performance bonus

Equity participation

Comprehensive health benefits

Job summary

Precede Biosciences, Inc. in Australia is seeking a senior Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs developed with biopharma partners.

You will own submissions from strategy through approval, serve as the regulatory lead on cross-functional teams, and translate complex evidence into clear regulatory positions, including drafting work directly.

Qualifications

• Experience leading regulatory submissions for pharma/biotech products.
• Ability to translate scientific data into regulatory positions.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Lead regulatory strategy and execution for products and companion diagnostics.
• Own submissions from strategy through approval and act as regulatory lead on cross-functional teams.

Job description

The Opportunity

Precede Biosciences is seeking a hands-on Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs developed with biopharma partners.

This is a senior individual contributor role with broad influence across the organization. You will own submissions from strategy through approval, serve as the regulatory lead on cross-functional and partner teams, and translate complex analytical, clinical, software, and bioinformatics evidence into clear regulatory positions. The role is well suited to someone who combines sound judgment with the willingness and ability to draft the work directly.

About Precede Biosciences

We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our seminal publication in Nature Medicine.

We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

The expected salary range for this role is $175,000 to $220,000 per year. Final compensation will reflect the candidate's qualifications, experience, and geographic location. Employees are also eligible for a performance bonus, equity participation, and comprehensive health benefits.

We believe in building an inclusive and balanced team, and we know that strong candidates may not meet every qualification listed.

Precede Biosciences is an equal opportunity employer. We do not discriminate based on race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other status protected by applicable law.

Precede Biosciences does not accept unsolicited resumes from recruitment agencies or external recruiters. No fees will be paid for unsolicited submissions.