Regulatory Affairs Associate - Drug Products

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

 

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.