Ground every answer in facts on this page and the original listing. We never invent Glassdoor-style reviews or salaries that are not in our data.
Expect scenario questions on combo-product CMC strategy, autoinjector/inhalation control strategies, health-authority interactions, and how you drive alignment across drug and device teams. Prepare concise examples of dossier leadership, major CMC changes, and remote stakeholder management. No interview scorecards are in the data.
Strong fit if you lead regulatory CMC for combination products (especially injectables/inhalation) and can operate remotely with global pharma stakeholders. Thin public culture data; weigh your device–drug CMC depth and director-level submission ownership against the sparse employee-sentiment signals.
As Director of Drug & Device Combo Reg.-CMC for autoinjectors/inhalation at Merck, a typical day centers on regulatory CMC strategy for combination products: aligning device and drug quality files, guiding dossier content for health authorities, reviewing change controls and tech transfer impact, and coordinating cross-functional CMC, device, quality, and clinical teams so submissions stay consistent and inspection-ready.
Role-relevant focus areas (no cert list or costs provided):
Yes—the listing flags remote (1), with a Glendale/Denver, Colorado location reference in the data.
Per the company summary, Merck Group is a long-standing German science company with Healthcare, Life Sciences, and Electronics lines (Wikipedia).
None—CERTS resources are empty, so no required certs or costs are specified here.
Website: merckgroup.com
The Merck Group, branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, with about 60,000 employees and a presence in 66 countries. The group includes around 250 companies; the main company is Merck KGaA in Germany. The company is divided into three business lines: Healthcare, Life Sciences and Electronics. Merck was founded in 1668 and is the world's oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies globally.
Public cache only — not an employee review.
Merck is seeking a Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC to lead regulatory chemistry, manufacturing, and controls activities for its autoinjector and inhalation delivery programs in a fully remote capacity. Based remotely, you will partner with cross‑functional teams to ensure that device‑combined products meet global CMC standards from early development through commercial launch. About the Role In this leadership position you will oversee the CMC regulatory strategy for combination products, guiding teams through the preparation of technical sections for INDs, NDAs, BLAs, and marketing authorizations worldwide. You will serve as the primary regulatory CMC contact for autoinjector and inhalation projects, ensuring alignment with device development timelines and quality expectations. What You'll Do Develop and execute CMC regulatory plans for autoinjector, inhalation, and other drug‑device combination products Author and review CMC modules of regulatory submissions, including comparability protocols, stability data, and manufacturing process descriptions Partner with device engineering, formulation, quality, and clinical teams to gather CMC information and resolve open issues Maintain awareness of evolving FDA, EMA, and other health‑authority guidance on combination product CMC requirements Provide regulatory CMC oversight during technology transfer, scale‑up, and lifecycle management activities Mentor junior regulatory scientists and contribute to functional best practices and training initiatives What We're Looking For Advanced degree (PhD preferred) in pharmaceutical sciences, engineering, chemistry, or a related discipline Substantial experience in CMC regulatory affairs for drug‑device combination products, particularly autoinjectors or inhalation systems Proven track record of preparing and defending CMC sections of global regulatory submissions Strong understanding of device design controls, materials, sterilization, and manufacturing processes as they relate to CMC Excellent communication skills with the ability to influence cross‑functional stakeholders in a matrix environment Familiarity with ICH Q8‑Q11, QbD principles, and FDA’s combination product jurisdiction policies Demonstrated leadership ability, including mentoring and project management experience About Merck Merck is a global healthcare leader dedicated to improving health and well‑being through innovative medicines, vaccines, and biologics. The company fosters a culture of scientific excellence, collaboration, and integrity, empowering employees to make a meaningful impact on patients worldwide. How to Apply To apply, complete your application directly on this page,…
Generated for personal interview prep · 2026-07-18 UTC · getajob.ai