Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals

Health Care

1K-5K (1750)

Founded 2012

$225M raised

43 open positions

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Regulatory Manager

2 hours, 28 minutes ago

United States

Full-time

Senior

Compliance Manager

Operations

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Precision For Medicine

Pharmaceuticals

1K-5K

Founded 2012

$225M raised

View All Jobs 43

Description

Provide regulatory guidance throughout the clinical development life cycle.
Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, routine amendments, scientific advice meetings, orphan designations, pediatric planning, and marketing applications.
Develop and review documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance with regulatory standards.
Represent Global Regulatory Affairs in project team meetings with internal and external stakeholders.
Lead regional or global projects as needed.
Oversee and coordinate Regulatory Affairs Specialists to meet submission targets for contracted programs.
Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership updated.
Assist in the development of Regulatory Affairs Specialists and other operational staff.
Provide input into regulatory strategy and timeline development for new study opportunities.
Support corporate quality initiatives across business units within clinical solutions.
Maintain current knowledge of laws, regulations, and guidelines governing drug development and approval.
Provide ICH GCP guidance, advice, and training to internal and external clients.
Represent Global Regulatory Affairs in business development meetings.

Requirements

Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
5+ years of relevant regulatory affairs experience.
Computer literacy with MS Office / Office 365.
Fluent in English.
Graduate or postgraduate education preferred.
Basic understanding of financial management preferred.
In-depth knowledge of the drug development process, including regulatory milestones.
Specialized knowledge of regulatory activities in at least one major region, such as the EU or US, including INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy.
Working knowledge of clinical trial methodology, including protocols and indications being studied.
Knowledge of regulations and guidance supporting pharmaceutical development.
Availability for domestic and international travel, including overnight stays.

Benefits

$106,000 to $151,000 USD estimated annual salary range.
Eligible for a discretionary annual bonus.
Health insurance and retirement savings benefits.
Life insurance and disability benefits.
Parental leave.
Paid time off for sick leave and vacation.
Remote work designation (#LI-Remote).

Interested in this position?

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