Senior Lead, Regulatory CMC

Job not on LinkedIn

🔥 2 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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TRIGA Consulting GmbH & Co. KG

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2012

💼 Consulting

🏥 Healthcare

🎯 Recruiter

Consulting • Healthcare • Recruitment

TRIGA Consulting GmbH & Co. KG is a recruitment and consulting firm based in Munich that specializes in the placement of skilled professionals and leaders in the pharmaceutical and medical device sectors. The company is committed to connecting qualified candidates with excellent career opportunities, utilizing their expertise in executive search and deep industry knowledge. TRIGA Consulting also offers personalized career advice and has a vast network to ensure effective and sustainable personnel solutions for their clients.

📋 Description

• Develop and implement regulatory CMC strategies for assigned products • Lead all product-related Regulatory CMC activities across the portfolio and ensure timely execution • Prepare, review, and maintain CMC documentation for regulatory dossiers • Develop the corresponding regulatory rationales • Assess national and international requirements and ensure regulatory compliance • Contribute to submission strategies • Support changes to and further development of existing products • Assess regulatory risks, particularly in connection with variation procedures • Develop appropriate mitigation measures • Work closely with internal departments, international partners, and external service providers • Provide subject-matter guidance to colleagues • Contribute to cross-functional improvement projects

🎯 Requirements

• Master’s degree in Pharmacy, Chemistry, Biology, or a comparable scientific discipline • At least 7 years of professional experience in Regulatory CMC within the pharmaceutical industry • Extensive experience with CMC dossiers, regulatory submissions, and the maintenance of approved medicinal products • Strong knowledge of national and international regulatory requirements • Experience providing functional leadership on complex projects and across interfaces • Matrix or direct people-management experience is an advantage • Strategic thinking • Structured and self-directed approach to work • Excellent communication skills when collaborating with internal departments and external partners • Excellent German and English language skills

🏖️ Benefits

• A responsible role offering significant scope to shape and influence within an international working environment • Flexible working models with the option to work remotely • Working-time account with time off in lieu • 30 days of annual leave • Individual internal and external training and development opportunities • Flexibly usable additional benefits budget • Access to an employee discount platform • Company and team events