Regulatory Affairs Specialist

First Some Stuff on Us:

We recognize that employees look and feel different in every company, so it’s important to first describe the principles that will drive success in the role prior to talking about the specific responsibilities and tasks. These are: 
1. An obsessive focus on the customer 
2. Being accountable to the customer as if we were their own employee
3. Understanding that strategy is only as good as the execution - and vice versa 
4. Placing a high value on teamwork
5. People are at the heart of the product

In short, we want to build a big but small company.

Amazing culture: Happy, Helpful, Humble, Hungry.
Get to work in one of the fastest growing industries in TX – Life Sciences
Part of an amazing team
Flexible time off with pay
Opportunity for growth!

We know that diversity makes for the best problem-solving and creative thinking. We are dedicated to adding new perspectives to the team and encourage everyone to apply if your experience is close to what we are looking for.  

 Opportunity Employer: Proxima is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.


The Regulatory Affairs Specialist- Drugs will provide support to the Regulatory Team and Clients on regulatory deliverables and client interactions for assigned projects. The Regulatory Affairs Specialist-Drugs is responsible for performing research, generating regulatory documents, and providing general regulatory guidance for drug regulatory projects . This role will report into the Director of Regulatory Affairs.

A Day In the life
  • Identify and interpret regulations, guidelines, literature, and any other pertinent information issued by applicable regulatory agencies and other regulatory or standard organizations
  • Interpret and identify key concepts in client documentation
  • Author regulatory assessments and regulatory strategy documents
  • Lead, author, and maintain regulatory submissions for clients to appropriate regulatory agencies
  • Leads and supports multidisciplinary teams in the development and authoring of regulatory documents, such as initial IND applications, IND amendments, meeting requests, and meeting packages
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
  • Provide expert guidance to clients on what documentation is necessary for major regulatory documents
  • Perform regulatory document management and regulatory document logs for clients
  • Contribute to the writing of subject matter content for blog posts and articles
  • Assist with the management of Project Management Software

Must Have Knowledge and Skills
  • Bachelor’s Degree or equivalent
  • 3 years of experience in US drug regulatory affairs
  • Experience in authoring and compiling INDs
  • Excellent analytical and communication skills
  • Ability to articulate regulatory and scientific concepts
  • Knowledge of the art of regulatory writing
  • Comfort in engaging with clients
Nice to Have Knowledge and Skills
  • Master's Degree or higher
  • Experience authoring and compiling NDAs, BLAs, or MAAs
  • Experience in vendor management
  • 1-2 years of consulting experience
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Ready for your next challenge? We're waiting for you.
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Ready for your next challenge? We're waiting for you.