A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
Sr. Director, Regulatory Science Newleos Therapeutics Boston, MA Job Details Full-time 17 hours ago Qualifications FDA submissions Investigational new drug (IND) applications ICH guidelines Pharmaceutical company experience Clinical trial support in drug product development
Full Job Description The Company:
Newleos Therapeutics is a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development. Newleos' clinical-stage pipeline was in-licensed from Roche and includes multiple oral small molecules targeting novel mechanisms across a broad range of indications, including generalized anxiety, social anxiety, substance use disorders, and cognitive impairment. For more information on the Company, please visit https://www.newleos.com
Position Overview:
The Sr. Director, Regulatory Science will be responsible for shaping and executing global regulatory strategies across our clinical programs. Reporting to the Chief Medical Officer (CMO), the Sr. Director will play a critical leadership role in interactions with regulatory authorities, including the FDA and EMA, and will ensure regulatory excellence across all development stages. This role requires deep expertise in neuropsychiatry drug development, early-to-late phase regulatory engagement, and a proactive, hands-on approach in a fast-paced, startup environment. This role is based in Back Bay, Boston, and follows a hybrid work model—three days per week (Monday, Tuesday, Wednesday) in the office and two days (Thursday and Friday) remote.
Responsibilities:
Lead global regulatory strategy for all clinical assets across development phases, ensuring alignment with corporate goals and compliance with FDA and EMA requirements. Serve as the primary point of contact with regulatory agencies, including preparation and leadership of key meetings (e.g., pre-IND, End-of-Phase 2, Scientific Advice). Oversee preparation, submission, and maintenance of regulatory documents (e.g., INDs, CTAs, briefing books, meeting packages, Orphan Drug applications, Fast Track/Breakthrough requests). Provide strategic guidance on clinical development plans, regulatory pathways, risk mitigation, and data requirements. Partner cross-functionally with Clinical, CMC, Nonclinical, and Quality to ensure regulatory alignment and timely submissions. Monitor regulatory intelligence and evolving guidelines in neuropsychiatry and CNS. Support regulatory aspects of business development, investor communications, and potential global filings.
Qualifications:
Advanced degree (PhD, PharmD, MD, or MSc) in life sciences or related field. Minimum 8+ years of experience in regulatory affairs or regulatory science in the biotech/pharmaceutical industry, with direct FDA and EMA interactions. Proven track record leading CNS or neuropsychiatry programs through IND/CTA to mid- or late-stage trials. In-depth understanding of regulatory frameworks (FDA, EMA, ICH) Experience managing regulatory strategy in a startup or small company environment is highly preferred. Strong scientific judgment, excellent communication skills, and the ability to operate strategically and tactically. Comfortable working in a lean, fast-moving, entrepreneurial setting. Newleos Therapeutics is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.
