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Regulatory Affairs Associate - Princeton, United States - Laboratoire Guerbet
Description
At Guerbet, we build lasting relationships so that to enable people to live better . This isOur 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.
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.
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.
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.
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.
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 listing.
Coordinate timeliness of annual payments of PDUFA and GDUFA fees to FDA.
Provide periodic updates about shortages of Guerbet drug products to FDA.
Coordinates compliance with Cares Act for drug substances and drug products
YOUR BACKGROUND:
Bachelor's degree is required as the minimum.
Master's degree in a scientific field is preferred, RAC preferred.
4 to 7 years of regulatory affairs experience in pharmaceutical industry
4 to 7 years of hands-on experience with preparation of e-CTD dossiers.
4 to 7 years of experience in FDA interactions and understanding of FDA processes.
Project management skills for timely publishing of e-CTD regulatory submissions.
Excellent interpersonal skills and ability to resolve conflicting points of view.
Good written and verbal communication and presentation skills are mandatory.
Convey scientific and complex regulatory issues clearly to ensure full understanding
Experience with maintaining a variety of regulatory affairs database systems.
Communication with external e-CTD publisher to assure timely submissions to FDA.
EQUAL EMPLOYMENT OPPORTUNITY
Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law.
The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws.
A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet.
Please inform the company's personnel representative if you need assistance completing this application or to otherwise participate in the application process.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email toWHY 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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