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Regulatory Affairs Associate

3 months ago

Princeton NJ United States Guerbet Full time
Guerbet is a human-scale company that aims to become a new global leader in medical imaging.

Pioneer in contrast media with 90 years' experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.

The company offers a comprehensive range of CT scan, Cath Lab, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostic (IRT) products, along with a range of injectors and related medical devices to improve patients' diagnosis, prognosis and quality of life.

More than 60,000 health professionals rely on Guerbet's contrast agents. Advancing in innovation solutions, the diagnosis of major diseases (cardiovascular diseases, cancers, diseases of the central nervous system) and interventional radiology while reconciling efficacy and cost containment, are at the heart of Guerbet's mission.

Its total workforce is of 2,700 employees. Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com and follow Guerbet on Twitter @GuerbetGroup / @GuerbetCareers.

WHAT WE'RE LOOKING FOR:

This is a key US regulatory role to ensure preparation, review and finalization of accurate and timely submissions of all US regulatory documents for medical devices and software driven medical devices. In collaboration with the Senior Regulatory team, this person will participate in meetings and interactions with FDA to establish the regulatory processes for the current and new drug products. This role is the key in ensuring the accurate and the timely submission of all Guerbet regulatory documents, staying current on all US federal regulations to ensure compliance, develop training programs and/or communications documents to meet regulatory requirements, and ensure that regulatory processes are understood and followed.

YOUR RESPONSIBILITES:

Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review.
Coordinate preparation, review, submission of e-CTD regulatory dossiers to FDA.
Identify relevant FDA CDER, FDA OGD and ICH guidances for drug products.
Provides regulatory advice to Guerbet RA team about required labeling changes.
Conduct regulatory e-CTD training with various Guerbet regulatory employees.
Maintain knowledge of existing and new regulations, standards and guidances.
Recommend changes to company procedures per updates in US FDA regulations.
Distribute updated information about FDA regulations, FDA and ICH guidelines.
Maintain regulatory files to obtain and maintain drugs product approvals.
Review promotional materials for compliance with DDMAC requirements.
Evaluates labeling of drug products per the current FDA labeling requirements.
Evaluate Guerbet ‘s CMC documents for compliance with FDA requirements.
Write regulatory standard operating procedures, work instructions and policies.
Advise project teams on pre-market and post-market regulatory requirements.
Consult about export and labeling requirements for clinical study compliance.
Compile and maintain regulatory documentation databases or systems.

YOUR BACKGROUND:

Bachelor's degree
3-4 yers of regulatory affairs experience in the phamaceutical industry
3-4 years of hands on experience with preparation of e-CTD dossiers
3-4 years of experience in FDA interactions and understanding of the FDA processes.
Project management skills for timely publishing of e-CTD regulatory submissions.

Why Guerbet?

Guerbet is a French based company with a Global reach. Our products and services are made available in more than 80 countries through our affiliates and network of distributors. We offer competitive benefits including but not limited to;

Eligible for medical benefits on start date.
Competitive 4% 401K match + 2% profit sharing contribution
Tuition reimbursement program for ongoing education
4 weeks of PTO
Opportunity to collaborate with colleagues around the world
We # Innovate # Cooperate # Care #Achieve at Guerbet.