Regulatory Affairs Consultant | CNS / Neuropsychiatry

Nexia; Massachusetts; Hybride; USD 207 000 - 317 000; Plein temps

Résumé du poste

Nexia, a CNS biotech company, is seeking a Senior Regulatory Affairs Consultant (fractional) to shape the US regulatory strategy for early and clinical development, with a preference for US presence and Boston proximity, and flexibility for remote work.

You will advise on IND milestones, guide FDA engagement with scientifically supported positions, and support pediatric development as programs progress. The role emphasizes practical, hands-on collaboration in a lean team.

Qualifications

• Senior regulatory affairs experience at VP level or equivalent.
• Background in CNS drug development, ideally including neuropsychiatry.
• Experience spanning early development and IND submissions through later-stage development; NDA submission experience is valuable.
• Substantial experience engaging directly with the FDA and influencing regulatory strategy.
• Experience in pediatric drug development, particularly transitioning programs from adult into pediatric populations.
• Experience developing regulatory approaches in novel indications or areas with limited precedent.

Responsabilités

• Shape US regulatory strategy across early and clinical development, keeping eventual path to registration in view.
• Advise on IND submissions and subsequent regulatory milestones, drawing on experience across the development lifecycle.
• Guide FDA engagement, developing clear, scientifically supported positions and advocating constructively for the programs.
• Work with the clinical team on regulatory considerations around trial endpoints, outcome measures, and potential new rating scales where established approaches may be insufficient.
• Support the transition from adult development into pediatric development, helping shape appropriate regulatory plans.
• Provide engaged, practical support to the leadership team, adapting priorities as programs progress.

Connaissances

Senior regulatory leadership

CNS drug development

Neuropsychiatry

FDA engagement

IND submissions

NDA submissions

Pediatric development

Regulatory strategy

Description du poste

Senior Regulatory Affairs Consultant | CNS / Neuropsychiatry

Fractional consulting opportunity

Location: US preferred; Boston presence advantageous, with flexibility for remote working

We're supporting a clinical-stage CNS biotech with finding a senior regulatory consultant to support the development of novel treatments for neuropsychiatric conditions.

This is an opportunity to work closely with an experienced leadership team in a lean biotech, helping shape regulatory strategy for programs in an area with limited established precedent.

We're looking for someone who combines substantial FDA experience with scientific judgement, creativity, and a practical, hands-on approach. Someone who can interpret guidance, challenge assumptions constructively, and identify credible routes forward when the development pathway is not straightforward.

The scope

• Shape US regulatory strategy across early and clinical development, keeping the eventual path to registration in view.
• Advise on IND submissions and subsequent regulatory milestones, drawing on experience across the development lifecycle.
• Guide FDA engagement, developing clear, scientifically supported positions and advocating constructively for the programs.
• Work with the clinical team on regulatory considerations around trial endpoints, outcome measures, and potential new rating scales where established approaches may be insufficient.
• Support the transition from adult development into pediatric development, helping shape appropriate regulatory plans.
• Provide engaged, practical support to the leadership team, adapting priorities as programs progress.

The experience we’re looking for

• Senior regulatory affairs experience at VP level or equivalent, with the ability to operate independently as a fractional consultant.
• A strong background in CNS drug development, ideally including neuropsychiatry.
• Experience spanning early development and IND submissions through later-stage development; direct NDA submission experience would be particularly valuable.
• Substantial experience engaging directly with the FDA and influencing regulatory strategy.
• Experience in pediatric drug development, particularly transitioning programs from adult into pediatric populations.
• Experience developing regulatory approaches in novel indications or areas with limited precedent, including navigating uncertainty around acceptable endpoints and outcome measures.

The approach matters just as much

• Creative and agile, with the confidence to explore scientifically sound approaches beyond established precedents.
• Comfortable with ambiguity and able to turn complex regulatory questions into clear recommendations.
• Willing to challenge assumptions and advocate for a program through constructive dialogue with the FDA.
• Personally engaged, collaborative, and comfortable contributing hands-on within a small team.
• Experience working in a lean biotech environment would be an advantage.