Regulatory Start Up Manager II

Premier Research Group; United States; Remote; USD 110,000; Full time

Job summary

Premier Research Group seeks a Regulatory Start Up Manager II to join their Global SSU team. This role involves developing regulatory submission plans and liaising with sponsors, requiring extensive experience in regulatory management and knowledge of FDA and EU regulations. Join a community dedicated to transforming life-changing ideas into new medical treatments.

Benefits

Health insurance

Retirement plans

Paid time off

Qualifications

• Minimum of 7 years professional experience in regulatory roles.
• At least 4 years as Regulatory Start-up Manager.
• Hands-on experience in global studies.

Responsibilities

• Develop regulatory submission project plans.
• Liaise with sponsors for document approval.
• Review submission components for regulatory compliance.

Skills

Regulatory knowledge

Project management

Communication

Education

University degree in pharmacy, medicine or related natural sciences

Job description

Regulatory Start Up Manager II page is loaded

Regulatory Start Up Manager II

Apply remote type Remote locations United States of America time type Full time posted on Posted Yesterday job requisition id R5246 Premier Research is looking for a Regulatory Start Up Manager II to join our Global SSU 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 Built for You. 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.

• We are Built by You. Your ideas influence the way we work, and your voice matters here.

• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech. Join us and build your future here.

What You'll Be Doing:

• Responsible for developing the Regulatory & start-up submission project plan. Is the driver for CA, EC and LEC submission as well other boards/evaluating bodies, import and export licenses, where applicable.

• Is the liaison with the Sponsor regarding approval and collection of all core documents, country submission packages and commination and adherence to timelines and deliverables

• Review master IP labels and provides feedback on its potential acceptability to regulatory authorities including issues related to country adaptation

• Assumes responsibility on deliverables in Regulatory and Start-up at the project level following the project requirements and the applicable rules. ·

• Produces and/or reviews submission components like the Patient Information Form/ICF.

• May participate in the review of the Investigational Medicinal Product Dossier (IMPD) in conjunction with other Subject Matter Experts

• May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.

What We Are Searching For:

• Education to university degree level (pharmacy, medicine or related natural sciences is a plus)

• Minimum of 7 years professional experience, including at least 4 years of previous experience as Regulatory Start-up Manager at a local/country level, for newly awarded studies containing countries from the same region, and may take a multi- region study in Start-up under supervision, or maintenance studies

• At least 2 years of hands-on experience in global studies

• Experience working on ample number of countries in global studies

• Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and start-up procedures

• Ability to work accurately and to interpret the relevant directives and guidelines

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $110,000 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

Why Choose Premier?

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.

Join Our Network

Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

About Us

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.