Job Description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

Job Overview

Due to our continued growth, we are seeking a highly experienced Regulatory Affairs Senior Consultant and provide strategic regulatory guidance, submission support, and compliance oversight for pharmaceutical products submitted to the US FDA and Health Canada. The ideal candidate will have deep expertise in FDA regulatory pathways, a solid understanding of US compliance requirements, and strong communication skills to interface with regulatory authorities and clients.

Location: Candidate must be based in Buffalo, Chicago OR Rockville.

Key Responsibilities

• Act as US Agent and primary point of contact for regulatory communications with the FDA (e.g., Type B meetings, pre-NDA, controlled correspondence).
• Act as the main regulatory liaison with Health Canada.
• Develop and implement US regulatory strategies aligned with client business objectives and applicable regulatory frameworks.
• Support regulatory activities from development to post-marketing, including:
• Review and/or drafting of CMC documentation.
• Preparation and submission of DMFs.
• FDA submissions (e.g., IND, NDA, BLA, ANDA, OTC monograph).
• Labeling development and FDA-compliant reviews.
• Health Canada submissions (e.g., NDS).
• Conduct dossier gap assessments and due diligence for the U.S. market.
• Oversee:
• Establishment Registration.
• Self-identification submissions under GDUFA /CARES Act.
• Drug Listing and Labeler Code Requests.
• Controlled Correspondence submissions.
• Use of CDER Direct or ESG systems for electronic submissions.
• Ensure ongoing compliance with evolving U.S. regulatory standards including:
• 21 CFR Title 21 (e.g., Parts 207, 210-211, 312-314).
• CARES Act, REMS, GDUFA.
• FDA and ICH guidance.

Qualifications

Education : Master’s degree (or higher) in Life Sciences, Chemistry, Biology, Pharmacy, or Biomedical Engineering.

Experience :

• Minimum 10 years in Regulatory Affairs within the pharmaceutical or biotech industry.
• Proven experience preparing and submitting regulatory dossiers to the US FDA.
• Direct experience interacting with regulatory authorities (FDA, Health Canada), including meeting participation and response management.
• Deep knowledge of US regulatory frameworks including 21 CFR, NDA/ANDA processes, and clinical trial requirements.
• Familiarity with FDA submission portals and electronic submission standards (eCTD, ESG, CDER Direct).
• Strong analytical, writing, and verbal communication skills.
• Fluency in English (both written and spoken).

Next Steps

Upon receiving your application, if a match is found, the Talent Acquisition department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

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