Remote: Senior Lead Regulatory CMC (m/w/d)

Remote•Remote

Full-timeRemoteremotejobsorg

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About this role

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

Posting details

Remote

Yes

Employment type

Full-time

Workplace type

Remote

Source

remotejobsorg

First seen

10/5/2026, 2:10:26 PM

Last seen

10/5/2026, 2:10:26 PM