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Regulatory Affairs Associate
3 months ago
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.
Are you ready to step into a pivotal role in the world of US regulatory affairs? We're seeking a dynamic individual to join our team, where you will play a key role in ensuring the accuracy and timeliness of regulatory submissions for medical devices and software-driven medical devices.
As a Regulatory Affairs Specialist at Guerbet, you will collaborate closely with our Senior Regulatory team, engaging in critical meetings and interactions with the FDA to shape regulatory processes for both our existing and upcoming drug products.
Your role is instrumental in ensuring the precise and timely submission of all Guerbet regulatory documents. You will stay at the forefront of US federal regulations to guarantee compliance, develop training programs and communication materials to meet regulatory requirements, and ensure that our regulatory processes are not only understood but also meticulously followed.
Join us in shaping the future of regulatory affairs at Guerbet. If you're ready to make an impact in the field and drive regulatory excellence, we want to hear from you. Your expertise will be pivotal in ensuring that our products continue to meet the highest standards of safety and compliance.
**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.
Determine type of submissions for proposed drug product and labeling changes.
Participate in internal or external CGXP and Pharmacovigilance audits.
Coordinates preparation of information or responses, as requested by FDA.
Evaluate data or reports that will be incorporated into regulatory submissions.
Review clinical protocols to ensure completeness, accuracy and integrity of data.
Escort inspectors during inspections and provide post-inspection information.
Participates in recall or market withdrawal with Guerbet USA and France teams.
Coordinate preparation of Drug Master files with CMC team at Guerbet France.
Author standard operating procedures pertinent to activities in regulatory affairs.
Interact with State Pharmacies to assure that business licenses are current.
Participate in Product Review Committees review of promotional materials.
Participates in post marketing commitment discussions with FDA CDER.
Submit promotional and marketing materials to FDA OPDP for the review.
Register drug substances and drug products manufacturing sites on annual basis.
Coordinate preparation of SPL for drug products and update annual drug list
