Associate Director – Regulatory Affairs

Job not on LinkedIn

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $170k - $195k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Parabilis Medicines

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Parabilis Medicines is focused on creating extraordinary medicines through its innovative Helicon™ peptide platform. The company aims to advance a new category of ultra-tunable peptide therapeutics designed to transform treatment possibilities for patients suffering from severe diseases, particularly cancer. By prioritizing groundbreaking changes in medicine rather than incremental improvements, Parabilis strives to have a life-changing impact on patients and their communities.

📋 Description

• Contribute to global regulatory strategies and provide tactical guidance to cross-functional teams • Anticipate and adapt to regulatory and business environment changes • Support end-to-end regulatory planning for INDs, NDAs/BLAs, briefing packages, and orphan drug applications • Oversee regulatory consultants and vendors for timely, compliant, strategic deliverables • Serve as regulatory liaison for the FDA and other global health authorities • Prepare materials for and support agency meetings • Communicate regulatory risks, timelines, and updates to senior leadership and project teams • Represent Regulatory Affairs on Project, Clinical, and Study Teams • Coordinate cross-functional regulatory submission teams and stakeholder contributions • Identify, select, and oversee vendors such as CROs • Ensure regulatory strategies comply with applicable regulations and guidances • Develop and maintain regulatory SOPs and best practices • Maintain regulatory intelligence and monitor global regulatory trends, legislation, and health authority expectations • Participate in regulatory due diligence and provide strategic input during business development evaluations

🎯 Requirements

• Bachelor’s degree in a scientific discipline or equivalent work experience required; advanced degree (MS, PhD, PharmD) preferred • 7+ years of experience in the pharmaceutical/biotech industry, with at least 4 years in Regulatory Affairs roles • Experience in oncology and across multiple development phases required • Demonstrated experience preparing and supporting global regulatory submissions, particularly NDA/BLA filings with the FDA • Global regulatory experience preferred • Solid working knowledge of the drug development process and global regulatory pathways • Good understanding of global regulatory guidelines and their practical application • Excellent interpersonal, collaboration, and leadership skills, with the ability to influence cross-functional teams • Highly organized with outstanding communication and project management skills to juggle multiple priorities effectively • Proactive, analytical, and detail-oriented problem solver with a strong strategic mindset • Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus • Ability to travel up to 10%

🏖️ Benefits

• Annual target bonus • Equity • Comprehensive suite of competitive benefits designed to support employees’ overall well-being