Job Description

Position: Associate Director, Regulatory Affairs

Location: Hybrid in Lexington, MA or Remote (UK option available)

Overview:

An innovative biotechnology organization is seeking a strategic and experienced regulatory affairs professional to support the advancement of a growing RNA-based therapeutic pipeline. This role will be instrumental in shaping and executing global regulatory strategies from early development through to registration and launch, with opportunities to contribute across multiple therapeutic areas, including both rare and prevalent diseases.

Key Responsibilities:

• Lead regulatory planning and execution for assigned development programs, including authoring and overseeing INDs, CTAs, and other global submissions

• Collaborate cross-functionally with Clinical, CMC, Quality, and Nonclinical teams to drive regulatory milestones

• Monitor evolving global regulatory guidelines (FDA, EMA, ICH) and assess implications for ongoing programs

• Identify regulatory risks and propose mitigation strategies

• Ensure completeness, consistency, and compliance across all submission documents

• Support health authority interactions and inspection readiness efforts

• Contribute to the development and improvement of internal regulatory processes and SOPs

Qualifications:

• BA/BS in Life Sciences (MS preferred)

• 8-12 years of regulatory experience in pharmaceutical/biotech product development

• Demonstrated experience authoring INDs, CTAs; familiarity with EU CTR is a plus

• Strong working knowledge of ICH, FDA, EMA regulations and eCTD structure

• Excellent critical thinking, attention to detail, and communication skills

• Ability to work independently in a fast-paced, collaborative environment

Ideal Candidate:

A proactive regulatory strategist with a strong foundation in global regulatory submissions and development lifecycle knowledge. Brings hands-on experience, thrives in a dynamic setting, and is motivated by the opportunity to contribute to transformative therapeutic advancements.

Job Tags

Remote work

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