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
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?
4 weeks of PTO
Exempt-employee benefits start on start date, non-exempt benefits start a month after hire
Competitive 4% 401K match + 2% profit sharing contribution
Tuition reimbursement program for ongoing education
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