Senior Manager, Regulatory Affairs, CMC

November 5

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000 employees

Founded 1961

Description

• Manage, evaluate, and complete regulatory projects • Develop strategies for CMC-related regulatory submissions • Support cross-functional teams on regulatory CMC strategies • Lead regulatory risk assessments and identify key issues • Provide regulatory CMC review of clinical protocols and investigator brochures

Requirements

• 7+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience • Proven record of experience in global submissions for clinical trial/marketing applications and subsequent response to HA queries • BA/BS degree in scientific discipline, MS/PhD preferred • In-depth knowledge of ICH requirements and US/EU regulatory requirements • Knowledge/experience with rest of world regions and GMP regulation and post-approval submissions is a plus • Experience in authoring complex technical documents and regulatory CTD (M2 and M3) sections • Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.) • Excellent oral and written communications skills are a must-have • Detail-oriented, self-motivated, and comfortable with broad responsibilities in an entrepreneurial, fast-paced environment

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness