Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

Regulatory Specialist in 2026: Role, Skills, Qualifications, Salary, and Pharma Career Path

A Regulatory Specialist connects regulatory submissions, GMP compliance, change control, and inspection readiness across the pharmaceutical lifecycle. This guide explains the role, essential skills, qualifications, salary factors, and career path for professionals working in pharmaceutical regulatory affairs.
  • Blog, Quality Management System
Pharmaceutical regulatory affairs professional reviewing regulatory submissions, change control records, and inspection readiness documentation.

BioNTech Pushes 25+ Oncology Trials Forward; Validation Readiness Becomes the Commercial Test

BioNTech has appointed Guido Oelkers as its next CEO as the German biotech prepares for a decisive return to oncology. Oelkers will take office by February 1, 2027, at the latest, inheriting falling COVID-19 vaccine sales, a deep cancer pipeline
  • News
BioNTech Pushes 25+ Oncology Trials Forward; Validation Readiness Becomes the Commercial Test

Pharma Trust Starts Before PR; GMP Compliance Becomes the Real Test

Pharmaceutical Executive examined how leading drugmakers build and measure trust across their organizations and found that the foundation starts before reputation, ESG, or public communication. It starts with safe, effective, high-quality medicines and genuine regulatory compliance. The analysis matters for
  • News
Pharma Trust Starts Before PR; GMP Compliance Becomes the Real Test

Halo Launches Sterile Fill-Finish: GMP Qualification Becomes Its Next FDA Milestone

Halo Pharma is preparing to launch a new sterile fill-finish platform in the United States, marking its first move into syringe, vial, and cartridge filling. The expansion responds to demand for domestic injectable capacity, while the Apotex partnership gives Halo
  • News
Halo Launches Sterile Fill-Finish: GMP Qualification Becomes Its Next FDA Milestone

Medical Device Regulatory Submissions in 2026: 510(k), De Novo, PMA, eSTAR, and FDA Approval Guide

Explore how FDA medical device submissions work across 510(k), De Novo, PMA, and eSTAR pathways. Learn how classification, predicate strategy, evidence planning, substantial equivalence, and quality documentation can support smoother premarket review and stronger regulatory readiness.
  • Blog, Medical Devices
Medical device premarket submission workflow showing eSTAR submission, predicate device comparison, substantial equivalence, and FDA premarket review.

US Pharmacopeia in 2026: USP–NF Standards, Monographs, General Chapters, and Pharmaceutical Compliance

Explore how USP-NF standards, monographs, General Chapters, and reference standards support pharmaceutical quality testing and GMP compliance. Learn which compendial requirements are mandatory, how teams manage updates, and what evidence laboratories should maintain for inspection readiness.
  • Blog, Quality Management System
Pharmaceutical quality laboratory applying USP monographs, reference standards, analytical testing, and GMP compliance controls.

BMS Bets $2.3B on Texas; One Campus Spans Three Drug Modalities

Bristol Myers Squibb plans to invest $2.3 billion in a new manufacturing campus at Generation Park in Houston, Texas. The company says the site will support next-generation medicines, create nearly 500 skilled jobs and expand U.S. production capacity. More importantly,
  • News
BMS Bets $2.3B on Texas; One Campus Spans Three Drug Modalities

USP 797 Compliance in 2026: Sterile Compounding Requirements, Cleanrooms, Training, and Inspection Readiness

Explore current USP 797 requirements for sterile compounding, cleanroom controls, personnel training, environmental monitoring, aseptic technique, and beyond-use dates. Learn how pharmacy and quality teams can strengthen inspection readiness and maintain reliable control over compounded sterile preparations.
  • Blog, Validation and Qualification
Sterile compounding technician performing aseptic technique inside a controlled cleanroom with environmental monitoring systems.

AI Spending Is Surging, Results Aren’t; Workforce Qualification May Explain Pharma’s ROI Gap

Pharma companies continue to increase AI investment, but expected gains in development timelines and success rates remain limited. In an August 10, 2026 analysis for Pharmaceutical Technology, Brian Drapeau argues that workforce qualification may be the missing link. The issue
  • News
AI Spending Is Surging, Results Aren’t; Workforce Qualification May Explain Pharma’s ROI Gap

EDQM Adds Three Immunoglobulin Tests; QC Labs Must Prepare by July 2027

The EDQM has introduced Ph. Eur. General Chapter 2.6.42 for procoagulant activity testing in human immunoglobulin preparations. EDQM announced the change in Strasbourg on 10 August 2026. The chapter will appear in Ph. Eur. Issue 13.3 in October and take
  • News
EDQM Adds Three Immunoglobulin Tests; QC Labs Must Prepare by July 2027