Senior Manager/Associate Director, Regulatory Affairs

📋 Description

• Develop and execute regional regulatory strategies in support of development programs
• Provide regional regulatory guidance and strategy for support of product development and
• Plan, compile, review, and submit regulatory documents, including initial INDs/CTAs/NDAs and
• Represent Regulatory at cross functional team meetings
• Act as regulatory study representative at cross-functional team meetings
• Provide strategic regulatory guidance internally on study-level decision-making

🎯 Requirements

• BA/BS degree in biological or physical sciences; advanced degree (e.g., PharmD or PhD) preferred
• Minimum 3 years pharmaceutical industry experience in regulatory affairs
• Knowledge of US FDA and international regulations (21 CFR, ICH, GCP, GMP, EMA)
• Experience supporting eCTD-formatted submissions (INDs, NDAs/BLAs, MAAs, annual reports)
• Experience coordinating responses to health authorities
• Proficient written and oral communication in English

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days