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About the Role

Premier Research is looking for a Regulatory Strategy Associate to join our Regulatory Affairs team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Responsibilities

Independently prepare IND Modules for routine submissions.
Support regulatory affairs leadership in preparation of complex submissions, using regulatory intelligence to support regulatory strategies and other regulatory deliverables (e.g., Orphan Designation Applications, Fast Track and Breakthrough Designations, Briefing Packages, etc.).
Perform thorough independent background research through all pertinent search engines for further in-depth research efforts related to medical and regulatory documents, filings, and/or submissions.
Ensure that documents appropriately evaluate and present data and methodology, accurately reflecting the information provided in scientific literature available in the public domain.
Navigate and obtain information for projects from all available resources.
Produce timely, scientifically accurate data summaries, ensuring documents are appropriate for inclusion in final reports and submissions to client and/or FDA.
Construct documents in a manner consistent with applicable regulations and guidance and client strategic intent, conforming to Premier Consulting’s internal Standard Operating Procedures (SOPs).
Serve as Regulatory representative in department discussions and present issues, challenges, and potential solutions accordingly.
Interface with international affiliates on regional regulatory strategy and implementation plans.

Requirements

3+ years of experience working in a CRO, pharmaceutical biotechnology, consulting, regulatory affairs, or device/diagnostics industry; industry experience may be considered in lieu of an advanced degree and a post advanced degree fellowship may be considered in lieu of industry experience.
Strong scientific verbal and writing skills.
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Ability to communicate and interact effectively within the department, across departments and on project team(s).
We are unable to support VISA sponsorship now or in the future for this role.

Skills

Scientific verbal and writing skills
Organizational skills
Writing skills
Communication skills
Time management skills

Location

Bay Area or Boston

Work Type

Full-time

Experience Level

3+ years

Education Level

Master’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD or PharmD preferred.

Salary/Compensations

$71,000.00 USD

Benefits

Health insurance
Retirement plans
Paid time off

About the Company

Premier Research is dedicated to providing compensation that is fair and competitive with market standards.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines.
Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need.
We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.
Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.
As a Premier team member, you have the power to make an impact, regardless of job title and location.
Our dedication to biotech and specialty pharma is unlike any other.
We provide our staff with innovative technologies and continuous learning.
Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.
Premier Research is a global clinical research, product development, and consulting company.
We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments.
Our team is inspired by this common purpose.
Premier is a place where you can change lives, and feel rewarded and celebrated.
We aim high - we will not stop until we reach our goals.
And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.

Equal Opportunity

All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.