Would you like to take responsibility for regulatory CMC matters throughout the entire product lifecycle and make a difference both strategically and operationally?
Our client is an international pharmaceutical company with a growing product portfolio. To support its drug portfolio, we are seeking an experienced professional for the role of:
Senior Lead Regulatory CMC (m/f/d)
Location: Remote/work from home with occasional travel to company locations
Responsibilities
Developing and implementing regulatory CMC strategies for the products under your purview
Managing all product-related regulatory CMC activities within the portfolio and ensuring timely implementation
Preparing, reviewing, and maintaining CMC documentation for regulatory submissions, as well as drafting the associated regulatory justifications
Assessing national and international requirements and ensuring regulatory compliance
Contributing to submission strategies and overseeing changes and further developments of existing products
Assess regulatory risks, particularly in connection with change management procedures, and develop appropriate measures
Collaborate closely with internal departments, international partners, and external service providers
Provide technical guidance to colleagues and participate in cross-functional improvement projects
Qualifications
Master’s degree in pharmacy, chemistry, biology, or a comparable scientific discipline
At least 7 years of professional experience in the Regulatory CMC field within the pharmaceutical industry
Extensive experience with CMC dossiers, regulatory submissions, and the management of approved drugs
Proficiency in handling national and international regulatory requirements
Experience in the technical management of complex projects and cross-functional interfaces; experience in matrix or direct management is a plus
Strategic thinking combined with a structured and independent work style
Strong communication skills when collaborating with internal departments and external partners
Excellent command of German and English
Benefits
A position of responsibility with creative freedom in an international work environment
Flexible work arrangements with the option to work remotely
Work-time account with time off in lieu and 30 vacation days
Customized internal and external professional development opportunities
A flexible benefits budget and access to a platform offering employee discounts
Company and team events
Interested? I look forward to receiving your application. Discretion is, of course, guaranteed.
Contact:
Silvio Di Meglio
089 809130720
Triga Consulting GmbH & Co KG is a consulting firm specializing in regulatory affairs and compliance support for the pharmaceutical industry. The company works with international pharmaceutical companies to provide expert guidance on regulatory matters, particularly in Chemistry, Manufacturing, and Controls (CMC) areas. They support clients throughout the entire product lifecycle, from development through post-approval changes, helping companies navigate complex national and international regulatory requirements. Their services include regulatory strategy development, CMC dossier preparation, submission management, and technical guidance on regulatory compliance.
