Department: Regulatory Affairs
Job Title: Manager/Senior Manager Regulatory Operations
Description:
In this position you will be responsible for managing the regulatory document planning and submission process for all regulatory documents, paper and electronic; overseeing implementation of electronic submission solution and vendor management; interacting with cross functional areas within ARIAD Pharmaceuticals and development partners; and, maintaining departmental archives.
Duties and Responsibilities:
The Manager/Senior Manager of Regulatory Operations will be responsible for ensuring ARIAD Pharmaceuticals prepares and submits regulatory documents in compliance with agency requirements and guidance documents in a timely manner.
- Maintain in depth knowledge of regulatory requirements
- Oversee implementation and maintenance of electronic submission solution including roll out of training and development of user guides and procedures
- Prepare and execute timelines for submission of regulatory documentation including identification and resolution of potential issues to avoid timeline impact
- Represent Regulatory Operations on cross functional submission planning teams
- Develop company standards and templates for regulatory submissions
- Ensure paper and electronic submissions comply with all requirements
- Ensure consistency within and across submissions
- Interact with regulatory agencies to obtain concurrence for electronic submission strategy
- Manage the assembly, review, and internal approval of submissions
- Contribute to the continuous improvement of the submission process
- Oversee the growth and development of the regulatory operations function to meet corporate goals
- Assess business trends, pending regulations, and emerging technologies for potential corporate impact, and plan accordingly
- Maintain corporate archives and logs for all regulatory agency communications
- Oversee the corporate archives and logs for all regulatory agency communications
Job Requirements:
BS degree, preferably in a science or business related field. Minimum of 5-8 years direct pharmaceutical / biotechnology regulatory operations experience with submission of an eCTD preferred, clear understanding of submission content and format requirements, excellent verbal, computer, and communication skills.
