Senior Regulatory Affairs Expert

PQE Group; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

PQE Group is looking for a Senior US Regulatory Affairs expert to oversee regulatory activities for pharmaceutical and medical device products. The role requires a deep understanding of FDA regulations and the ability to develop compliance strategies while collaborating with global teams. Ideal candidates will have advanced degrees and at least 15 years of experience in regulatory affairs.

Qualifications

• Minimum 15+ years of regulatory affairs experience.
• Extensive experience leading FDA interactions and regulatory submissions.
• Experience with biologics, small molecules, generics, or combination products preferred.

Responsibilities

• Develop regulatory strategies for new and existing products.
• Lead preparation and submission of INDs, NDAs, BLAs, ANDAs, and DMFs.
• Act as the primary contact point between the company and the FDA.

Skills

Knowledge of US FDA regulations

Regulatory strategy development

Leadership in FDA interactions

Regulatory compliance

Regulatory intelligence

Education

Advanced degree (PharmD, PhD, MD, MS) in Pharmacy or related field

Tools

Microsoft Office Suite

Adobe Acrobat Pro

Job description

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Direct message the job poster from PQE Group

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:

The Senior US Regulatory Affairs senior expert leads and oversees all regulatory activities related to the development, approval, and post-market compliance of pharmaceutical, biologic, and/or medical device products in the United States. This role ensures compliance with FDA regulations, provides strategic regulatory guidance, and manages interactions with the U.S. Food and Drug Administration (FDA) to support the company’s business objectives.

Responsibilities:

• Develop global and regional regulatory strategies for new and existing products.
• Optimize and control the registration processes, ensuring compliance of products and processes
• Compile and update regulatory dossiers, according to international guidelines ( FDA, ICH)
• Ensure that submissions are of high quality and meet all regulatory requirements
• Lead the preparation and submission of INDs, NDAs, BLAs, ANDAs, DMFs, and other regulatory filings.
• Ensure alignment with FDA regulations, ICH guidelines, and GxP (GMP, GCP, GDP) compliance.
• Provide regulatory intelligence and risk assessment for US market entry and lifecycle management.
• Collaborate with global regulatory teams to ensure consistency in regulatory approaches.
• Act as the primary contact point between the company and the FDA.
• Lead FDA meetings, including pre-IND, pre-NDA/BLA, Type A/B/C meetings, and Advisory Committee interactions.
• Ensure compliance with post-marketing requirements (PMRs), REMS programs, pharmacovigilance, and advertising/promotion regulations.
• Oversee responses to FDA inquiries, warning letters, 483 observations, and regulatory audits.
• Supervise the preparation, review, and submission of regulatory documents in eCTD format.
• Lead regulatory due diligence for product acquisitions, partnerships, and in-licensing.
• Ensure compliance with labeling requirements, advertising & promotional materials, and digital marketing regulations.
• US trainings preparation on US legislation upon client’s request
• BD for RA services, client's call support, RFP and proposal draft and review

Qualifications:

• Education: Advanced degree (PharmD, PhD, MD, MS) in Pharmacy, Regulatory Affairs, Life Sciences, or a related field.
• Experience: Minimum 15+ years of regulatory affairs experience in the pharmaceutical, biotech, or medical device industry.
• Extensive experience leading FDA interactions and regulatory submissions.
• Strong knowledge of US FDA regulations (21 CFR, FD&C Act, ICH, GxP)
• Experience with biologics, small molecules, generics, or combination products preferred
• FDA Electronic Submissions Gateway (ESG) for regulatory filings.
• Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) – for regulatory reports, presentations, and correspondence.
• Adobe Acrobat Pro

Next Steps

Upon receiving your application, if a match is found, the Recruiting 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 a 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.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting, Engineering, and Quality Assurance

• Industries

  Business Consulting and Services, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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