Sr. Regulatory Affairs Specialist II (NDA Submissions)

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.

What is the Primary Objective of the Sr. Regulatory Affairs Specialist II?

The ideal candidate will have experience with US FDA drug applications, including preparation of INDs/NDAs, submission management, lifecycle maintenance, and working with multi-disciplinary teams. Also desired is experience in developing regulatory strategies for both internal and external Sponsored projects and acting as liaison between FDA and the Sponsor.

Your Main Responsibilities And Duties Include

• Management of assigned regulatory submissions, including communicating timelines and coordinating required content as per submission content plan.
• Planning, compiling, publishing, and submitting Regulatory documents for INDs and NDAs, including Amendments, Supplements, and Meeting materials to the FDA. Occasional support related to BLA, IDE, and PMA applications may be required.
• 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.
• Attending multi-disciplinary team meetings as requested.
• Maintaining Regulatory submission and correspondence archive/records.
• Providing publishing support to the Medical Writing group, as requested.
  
  

To Succeed In This Position

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

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 candidate must be either currently residing in San Diego, CA or willing to relocate.
  
  

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!