Director, CMC, FDA Experience (EMEA/INDIA)
Job details
Description At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a Director, CMC at Allucent, you are responsible for assisting clients with CMC and related pharmaceutical development activities of drug, biologic or medical device products. The Director, CMC leads and/or participates in Health Authority (HA) communications including correspondences with the FDA and EMA, and reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents, including new drug market applications (e.g., INDs, BLAs, NDAs, IMPDs). In this role your key tasks will include:
Requirements To be successful, you will possess:
Benefits Benefits of working at Allucent include:
Disclaimers:
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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