Sr. Regulatory Associate- Project Management

Overview

Who Are We? Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You? You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing, is worth doing right.

You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

The ideal candidate will have experience leading regulatory project teams for US FDA drug applications, including strategic planning for INDs/NDAs, managing submission timelines and resources, and coordinating cross-functional teams. Also desired is experience in developing and executing regulatory project plans for both internal and external Sponsored projects, managing interactions with FDA and Sponsors, and ensuring project deliverables meet quality and compliance standards.

• 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

• You should have a 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.
• You must have a good understanding of FDA regulations relating to investigational drug/biologic/device development, submission requirements, and regulatory strategy development.
• Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable.

The most likely starting base pay range for this position is $100,000 to $125,000 per year. Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.

Please note the ideal candidate would reside in San Diego, CA; however, we will consider qualified remote candidates.

We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

If you are smart and good at what you do, we welcome you to apply!