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Premier Research · 8 hours ago

Regulatory Strategy Associate

Newark, CA

Full-time

Onsite

Entry Level

$75K/yr - $75K/yr

2+ years exp

Premier Research is looking for a Regulatory Strategy Associate to join our Regulatory Affairs team. In this role, you will support biotech, medtech, and specialty pharma companies in transforming innovative ideas into new medicines and devices by preparing regulatory submissions and conducting thorough research.

BiopharmaBiotechnologyHealth CarePharmaceutical

No H1B

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

Qualification

Regulatory AffairsScientific WritingIND Modules PreparationRegulatory IntelligenceCommunication SkillsOrganizational SkillsTime Management

Required

Master's degree, or international equivalent from an accredited institution, in a science or health related field

2+ 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