Senior Manager – Corporate Regulatory Affairs & CMC (m/f/d)
This position is with Randstad Switzerland, seeking an experienced Senior Manager for Corporate Regulatory Affairs & CMC in the pharmaceutical sector. The role is based at their headquarters in Bubendorf and involves leadership within the Corporate Quality Organization.
The main focus is on defining and harmonizing corporate regulatory standards across multiple business units and international sites.
Key Responsibilities
* Develop and maintain corporate Regulatory Affairs & CMC standards across three business units and 8 sites.
* Act as Business Process Owner for regulatory systems, ensuring compliance with requirements.
* Support local regulatory teams on improvement initiatives and projects.
* Manage regulatory documentation such as DMFs, INDs, IMPDs, NDAs, and MAAs.
* Coordinate CMC regulatory activities and support project teams.
* Chair the Corporate RAC organization and maintain related documentation.
* Oversee eCTD submission software usage and maintenance.
Your Profile
* Ph.D. in Chemistry, Pharmacy, or related field.
* Extensive knowledge of regulatory affairs for drug substances/products, especially CMC development.
* Understanding of GMP regulations.
* Experience with eCTD systems and electronic submissions.
* At least 5 years in Regulatory Affairs within a GMP environment.
* Experience managing regulatory interactions with authorities and clients.
* Leadership skills, with team management or consultancy experience preferred.
* Strong intercultural and communication skills in English; German is a plus.
* Proactive and flexible mindset.
This role offers an opportunity to lead strategically in a global pharmaceutical environment. If you are passionate about regulatory excellence, we would like to hear from you.
Apply now or contact us for more information.
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