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Ottimo Pharma · 11 hours ago

Director/Executive Director, Regulatory Affairs

United States

Full-time

Remote

Director/Executive

$200K/yr - $300K/yr

10+ years exp

Ottimo Pharma is a company focused on developing oncology programs, and they are seeking a Director/Executive Director of Regulatory Affairs to oversee regulatory activities for clinical trials. The role involves managing regulatory submissions, collaborating with health authorities, and ensuring compliance with regulatory standards.

BiotechnologyHealth CarePharmaceutical

Hiring Manager

Josh Haggerty

Responsibilities

Take end-to-end ownership of regulatory activities for assigned oncology programs, across the full clinical trials cycle, from planning through execution and follow-through

Operate with a “to-do” mentality—anticipating what needs to be done, driving tasks to completion, and ensuring nothing falls through the cracks

Proactively identify regulatory risks, gaps, or delays impacting clinical trial initiation, conduct and expansion and take responsibility for proposing and implementing solutions

Maintain accountability for timelines, quality, and completeness of all regulatory deliverables supporting respective clinical trials

Translate high-level regulatory strategy into clear, executable plans, timelines, and deliverables as aligned with clinical development plans

Lead the preparation, coordination, and submission of INDs, CTAs, amendments, and annual reports, with hands-on involvement as needed

Draft, review, and finalize regulatory documents including briefing packages, agency responses, and meeting documentation

Provide regulatory input into relevant clinical documents including protocol development, amendments, informed consent forms, IB, safety reporting, etc. Support the review and finalization of trial-related regulatory submissions including local ethics submissions as needed

Drive applications for regulatory designations and expedited pathways (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, etc…)

Lead and support interactions with health authorities (FDA, EMA, and others), ensuring thorough preparation and follow-up

In coordination with clinical, preclinical, translation, CMC and quality, ensure regulatory considerations are embedded early and consistently into program plans and execution

Coordinate and manage external regulatory vendors/consultants as well as regulatory interactions with CROs, holding them accountable for high-quality and timely output

Stay current on global regulatory developments, emerging data, and relevant industry news and proactively assess their impact on active and future programs

Step outside of defined responsibilities when needed to ensure overall program success

Qualification

Regulatory AffairsOncology Drug DevelopmentIND/CTA SubmissionsHealth Authority InteractionsRegulatory StrategyAccountabilityCommunication SkillsOwnership

Required

Advanced degree (PhD, MD, PharmD, or MSc) in life sciences, regulatory affairs, or a related field

10+ years of regulatory affairs experience, with a strong track record in oncology drug development

Preferred

Proven hands-on experience leading IND/CTA submissions and early-stage oncology development globally with direct support of clinical trial programs

Direct involvement in health authority interactions, including preparation and follow-up for FDA, EMA and other health authority meetings

Strong understanding of oncology regulatory requirements, preferably for biologics and immuno-oncology agents

Experience working in lean, startup, or high-growth environments with limited infrastructure including having successfully managed external regulatory vendors/consultants

Demonstrated ability to take ownership, work independently, and deliver results without extensive direction

Excellent written and verbal communication skills, with the ability to clearly articulate regulatory strategy and execution needs

A strong sense of urgency, accountability, and pride in delivering high-quality work