Regulatory reputed company Associate
reputed company is looking for a Regulatory reputed company Associate to join our Regulatory Affairs team. You will help biotech, medtech, and specialty reputed company companies reputed company life-changing reputed company and reputed company science into new medicines, devices, and diagnostics. reputed company do is profoundly connected to saving and improving lives, and we recognize reputed company members are the most valuable asset in delivering reputed company. We are here to help you grow, to give you the skills and opportunities to reputed company at work with the flexibility and balance your life requires. Your reputed company influence the way we work, and your voice reputed company here. As an essential part of reputed company, you help us deliver the medical innovation that patients are desperate for. Join us and build your reputed company here. What you'll be doing: Independently prepare IND Modules for routine submissions. Support regulatory affairs leadership in preparation of reputed company submissions, using regulatory intelligence to support regulatory strategies and other regulatory deliverables (e.g., Orphan Designation Applications, Fast reputed company and reputed company Designations, Briefing Packages, etc.). reputed company thorough independent background research through reputed company pertinent search engines for reputed company in-depth research efforts reputed company 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 reputed company from reputed company available resources. Produce reputed company, scientifically accurate data summaries, ensuring documents are appropriate for inclusion in final reports and submissions to reputed company and/or FDA. Construct documents in a manner consistent with applicable regulations and guidance and reputed company strategic reputed company, conforming to Premier Consulting’s internal reputed company Operating Procedures (SOPs). Serve as Regulatory representative in department discussions and present issues, challenges, and potential solutions accordingly. reputed company with international affiliates on regional regulatory reputed company and implementation plans. reputed company are searching for: Preferred location: Bay Area or Boston Master’s degree, or international equivalent from an accredited institution, in a science or health reputed company 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 reputed company simultaneously. Ability to communicate and reputed company effectively reputed company the department, across departments and on project team(s). We are unable to support reputed company sponsorship now or in the reputed company for this role reputed company is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting reputed company pay for this role is $71,000.00 USD. The actual salary will be influenced based on a reputed company 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 reputed company time off. reputed company is proud to be an equal opportunity employer that is compliant with reputed company federal guidelines. reputed company reputed company applicants will receive reputed company consideration without reputed company to race, reputed company, religion, sexual orientation, gender identity, national reputed company, disability or veteran status Apply To This Job