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Regulatory Studio - Associate Director, Precision Medicine & Digital Health

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Bachelor's degree required; advanced degree preferred, 5 years in the industry, 4+ years in Medical Device Regulatory Affairs, Experience with in vitro diagnostics regulations, Knowledge of clinical trial assay (CTA) requirements, Understanding of global regulatory requirements.

Key responsabilities:

Lead global regulatory strategy for biomarkers and diagnostic tests
Co-lead marketing application submission teams
Develop global submission and health authority interaction plans
Contribute to rapid response teams for clinical trial queries
Ensure compliance with global regulatory requirements

VARITE INC Information Technology & Services Large https://www.varite.com/

1001 - 5000 Employees

See more VARITE INC offers

Job description

Job Description

Job Title: Regulatory Studio - Associate Director, Precision Medicine & Digital Health

Location: Remote

Must Have List

In vitro diagnostics regulations in precision medicine under US and EU regulations
Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements
Has built a diagnostic device regulatory strategy plan for a biomarker-driven trial
Kept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drug

Position Responsibilities

Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas
Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans.
Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
Contribute in the developing of target labeling.

Degree / Experience Requirements

Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience

Key Competencies

Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within Client and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development.
Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.
Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions.
Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
Ability to apply project management techniques within teams and effectively manage meetings.
Demonstrated ability to breakdown complex, scientific content into logical components.
Ability to coordinate global activities, facilitate issue resolution and conflict management.
Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
Demonstrated ability to negotiate with and influence others.
Understanding of strategic and tactical role for the drug development process.
Understanding of general global regulatory requirements for drugs in development.
Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.