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Therapeutics Inc. · 1 month ago

Sr. Regulatory Associate- Project Management

San Diego, CA

Full-time

Onsite

Senior Level

$100K/yr - $125K/yr

6+ years exp

Therapeutics Inc. is a full-service dermatology CRO with over 25 years of experience, dedicated to taking products from concept to approval. They are seeking a Sr. Regulatory Associate- Project Management to lead regulatory project teams for US FDA drug applications, manage submission timelines, and coordinate cross-functional teams.

BiotechnologyHospitalityMedicalTherapeutics

Responsibilities

Leading and managing regulatory submission projects from initiation through completion, including defining project scope, timelines, deliverables, and resource requirements

Developing comprehensive submission content plans for INDs, NDAs, Amendments, FDA meeting packages, and other key regulatory activities. Occasional oversight of BLA, IDE, and PMA projects may be required

Coordinating cross-functional project teams including Medical Writing, Clinical Operations, Biostatistics, Product Development, and external consultants

Preparing regulatory administrative content included as part of a regulatory submission or application

Assisting primary/technical writers to ensure submission compliance with FDA eCTD formatting requirements

Reviewing submission components for quality and completeness

Serving as primary liaison between project teams, sponsors, and regulatory authorities

Qualification

Regulatory project managementFDA submission experienceIND/NDA application knowledgeECTD submission knowledgeCross-functional team coordinationCommunication skillsAttention to detailProblem-solving skills

Required

Bachelor's-level degree in scientific related field or a combination of education and industry experience

At least six (6) years of prior regulatory experience in the pharmaceutical industry

Must have successfully led (or played key supportive role) in at least one IND (or NDA) application from initial planning through submission

Strong project management skills, including good communication and interpersonal skills, with demonstrated ability to manage multiple projects simultaneously

Good understanding of FDA regulations relating to investigational drug/biologic/device development, submission requirements, and regulatory strategy development

Preferred

Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software

Company

Therapeutics Inc.

Founded in 1997

San Diego, California, USA

51-200 employees

http://www.therapeuticsinc.com

Funding

Current Stage

Growth Stage

Total Funding

$3M

2011-01-28Series Unknown· $3M

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