Description: Our client is currently seeking a Senior Manager / Associate Director US Regulatory Strategy
The Senior Manager / Associate Director US Regulatory Affairs for Global Development Projects will participate as a global team member focused on development projects and due diligence efforts.
RESPONSIBILITIES
Provide regulatory strategy and tactical support for assigned projects.
Contribute to developing global / regional regulatory strategies for multiple clinical development projects at all stages (Pre-IND through NDA submission and approval).
Support and perform with limited oversight larger submissions, such as IND applications and NDAs, including organizing the submission development and review process and timeline, preparing sections, reviewing for completeness, accuracy, and appropriateness.
Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed.
Interpret and advice regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance.
Establish contact with the FDA as required to support developmental programs.
Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
MINIMUM JOB REQUIREMENTS
Bachelor's degree in Science (e.g. Chemistry, Pharmacy, Biochemistry). Master's degree in Science related field strongly preferred.
Minimum of 6 years of Pharmaceutical industry experience with at least 4 of those years in Clinical Development Operations and Regulatory positions.
Working knowledge and experience in regulatory submissions and product life cycle management.
Broad range of experience to include Pre-IND and Phase I clinical development through NDA filing is sought (though not necessarily with same compound).
Knowledge of drug regulations and guidances with ability to apply them to complex regulatory issues and requirements.
Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
