JOB PURPOSE:

Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. Assists senior regulatory leaders with the development of documents to support desigations and other health authority programs and requirements, health authority responses, and global regulatory planning.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
• Track safety reports and coordinate submissions to US INDs.
• Assist Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.
• Assist with developing and implementing strategies to ensure compliance with HA requirements.
• Respond to requests for information from regulatory bodies.
• Serve as liaison with FDA.
• Work collaboratively with consultants and contractors to accomplish regulatory activities and submissions.
• Contribute to department initiatives.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor’s degree in related discipline and a minimum of seven years of related experience; or,

• Master’s degree in related discipline and a minimum of five years of related experience; or,
• PhD degree in related discipline; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

• Works independently and with others to contribute to plans, complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
• Gathers, maintains and applies regulatory knowledge to complete routine work.
• Provides verbal and written communications that are clear and easy to understand. Provides timely and appropriate information updates to departmental management and colleagues.
• Good interpersonal skills, understanding of differing views; participates in reaching an agreed upon resolution.
• Works collaboratively with team members to achieve common objectives.
• Applies knowledge of organizational objectives and adopts an analytical approach to solve problems relevant to the role.
• Leads self by managing and executing own work, acts with integrity and builds trust with colleagues.

JOB COMPLEXITY:

• Capable of following predefined procedures for specific tasks.
• Capable of identifying task-related challenges and prioritizing activity accordingly.
• Identifies and escalates issues that may have a broader impact.
• Implements solutions to address any task-related challenges.

WORKING CONDITIONS:

• Travel approximately 10%

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