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Manager, Regulatory Affairs

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree in science or health related field, PhD preferred., 8+ years' experience in CRO, pharmaceutical, biotechnology, or device/diagnostics industry., 5-6 years progressive regulatory affairs experience., Knowledge of regulatory requirements, including ICH and FDA..

Key responsabilities:

Prepare & oversee regulatory filings for multinational trials.
Review clinical trial & marketing application documents.
Serve as regulatory representative on project teams.
Lead global regulatory activities under supervision.

Premier Consulting Biotech: Biology + Technology Scaleup https://premierconsulting.com/

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Job description

Description

Premier Consulting, a division of Premier Research, is seeking a Manager of Regulatory Affairs. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.

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 BiotechTM. Join us and build your future here.

What You'll Be Doing:

Prepare submissions and oversee the maintenance of regulatory filings to support multinational trials (i.e., INDs, Clinical Trial Applications [CTAs], amendments, safety updates, and Annual Reports).
Review clinical trial documents including clinical protocols/reports, investigator brochures and nonclinical reports.
Assist in the preparation and review of regulatory filings to support U.S. and international marketing applications, applications under review by health agencies, and post-approval products (i.e., NDAs, supplements, Marketing Authorisation Applications [MAAs], variations, Annual Reports).
Serve as the regulatory representative on project teams, manage regulatory timelines, and provide strategic input.
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 guidances and client strategic intent, conforming to Premier Consulting’s internal Standard Operating Procedures (SOPs).
With some supervision lead global regulatory activities for pediatric investigation plans/pediatric study plans, Orphan Drug applications, Breakthrough Designation requests.

What we are searching for:

Bachelor’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD preferred.
8+ years’ experience in a CRO, pharmaceutical, biotechnology or device/diagnostics industry, an advanced degree will be considered in lieu of a portion of industry experience.
5-6 years progressive regulatory affairs experience in a CRO, pharmaceutical, biotechnology, or device/diagnostics company.
2-3 years supervisory/management experience preferred.
Knowledge of regulatory requirements, including ICH and FDA.
Excellent organizational, writing (scientific and regulatory), communication, and time management skills needed to manage multiple ongoing projects simultaneously.

Why choose Premier?

Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
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 opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

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

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