Regulatory Strategy Associate
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. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
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.
What you'll be doing:
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.
What we are searching for:
Preferred location: Bay Area or Boston
Master’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD or PharmD preferred.
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
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $71,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
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.
What you'll be doing:
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.
What we are searching for:
Preferred location: Bay Area or Boston
Master’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD or PharmD preferred.
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
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $71,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status