Senior Regulatory Affairs Manager

A company is looking for a Regulatory Affairs Senior Manager - Regional Regulatory Lead. Key Responsibilities: Implement the US regulatory plan and obtain Clinical Trial Authorizations and Marketing Application approvals Develop US regulatory strategies and provide regulatory guidance to optimize product development Maintain compliance with regulations and manage relationships with regulatory agencies Required Qualifications: Doctorate degree with 2 years, Master's degree with 4 years, Bachelor's degree with 6 years, Associate's degree with 10 years, or High school diploma with 12 years of experience in regulatory or pharmaceutical drug development Experience with regulatory submissions (e.g., INDs or CTAs) Knowledge of regulatory principles and national legislation regarding medicinal products Experience interacting with regulatory agencies Understanding of drug development processes and regulatory activities

Apr 2, 2025 - 00:22

A company is looking for a Regulatory Affairs Senior Manager - Regional Regulatory Lead. Key Responsibilities: Implement the US regulatory plan and obtain Clinical Trial Authorizations and Marketing Application approvals Develop US regulatory strategies and provide regulatory guidance to optimize product development Maintain compliance with regulations and manage relationships with regulatory agencies Required Qualifications: Doctorate degree with 2 years, Master's degree with 4 years, Bachelor's degree with 6 years, Associate's degree with 10 years, or High school diploma with 12 years of experience in regulatory or pharmaceutical drug development Experience with regulatory submissions (e.g., INDs or CTAs) Knowledge of regulatory principles and national legislation regarding medicinal products Experience interacting with regulatory agencies Understanding of drug development processes and regulatory activities