Regulatory Affairs Associate - Drug Products

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Date: May 29, 2024

Location:

Princeton, NJ (USA), US

Job Type: Graduate

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

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.

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 to careers@guerbet.com.

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