Remote Regulatory CMC Manager

• This position is REMOTE, EST hours.
• Looking for CMC Experience (working knowledge of CTD Module 3 preferably; ability to assess that documents and responses received from SMEs are appropriate and complete to close gaps)
• This role is responsible for supporting the GRA Compliance department. Most of the time spent will be on the support of the CMC Compliance Project. The CMC Compliance Project is a significant effort undertaken by GRO and is transitioning from analysis and strategy setting to completion of the mitigation plans.
• This role will interact with colleagues at all levels of management in the following functions/roles: CMC, Global and Site QA, Local Operating Company Regulatory Leads, Takeda Manufacturing and Testing Partners, Global Regulatory Leads,
• The person in this role will work with and under the direction of GRA Compliance staff to assure completion of remediation activities and assure all gaps are closed or managed within the appropriate Takeda processes (Change Control, current or future Submissions).
• Experienced with end-to-end Change Control process is a plus but not required.

Job Requirements:

• Support regulatory affairs personnel with clinical sections of regulatory submissions, and study related communication with regulatory agencies
• Supervise employees within the regulatory affairs department
• Support related regulatory submission activities
• Assisting other functional areas within regulatory affairs
• Coordinate regulatory labeling and promotional submissions
• Manage drafting of regulatory submissions
• Facilitate approval of the regulatory submissions
• Approve internal operating procedures related to regulatory affairs
• Develop regulatory submission strategies for FDA
• Assemble regulatory commitments and negotiate with regulatory agencies
• Develop and implement documented regulatory affairs processes
• Overseeing document control and regulatory affairs personnel
• Written in support of regulatory submissions
• Provide regulatory expertise to ensure that regulatory submissions meet local requirements
• Lead all regulatory strategies and manage the regulatory process to ensure approval from various regulatory agencies
• Develop regulatory approval strategies for products
• Maintaining awareness of changes in regulatory requirements for effective regulatory submissions
• Build a regulatory affairs department to support current and future clients in regulatory oversight and support regulatory filings
• Prepare submissions and reports for regulatory agencies
• Providing regulatory requirements and assisting with the development of regulatory strategies for product development and regulatory approvals