Vice President, Regulatory Affairs NA
|Job Title:||Vice President, Regulatory Affairs NA|
|Contact Name:||Pavlina Bullaj|
|Job Published:||February 05, 2018 22:39|
Vice President, Regulatory Affairs - NA
Working together with one of our international clients, SciPro Global are actively searching for a Vice President, Regulatory Affairs, NA to join a strong and established organization to lead a great team of regulatory affairs professionals.
My client, a pharmaceutical company based on the East Coast, is looking for someone who wants to join a strong internationally team to make a difference and change lives. As the Vice President, Regulatory Affairs, NA you will be responsible for the development and implementation of the regulatory strategy for the United States and Canada across the business generics, brand and OTC products. As well as the strategy, you will also be responsible for the oversight of the day-to-day operations and of the planning, preparation, review and evaluation of documents for submission to the FDA.
- Provide daily oversight, counsel and guidance to Regulatory Affairs staff members and to other functional areas and manages regulatory activities for new and approved products to meet both FDA requirements and company objectives.
- Oversees the processes governing preparation of major regulatory filings, including INDs, BLAs, NDAs, and ANDAs
- Provide advice, regulatory guidance and status reports to senior management, as appropriate.
- Maintain positive relationships with FDA as primary liaison on submissions, communications and specific projects.
- Provide strategic regulatory guidance for new and approved products, as needed. Provide input to minimize regulatory issues and help prevent unnecessary regulatory delays.
- Oversee Distribution Regulatory Compliance activities and coordination across client facilities, including State Licensing, DSCSA, and DEA compliance.
- Provide daily direction to Regulatory Affairs staff including Regulatory professional leaders, administrative, documentation support, labeling, and regulatory submission management functions. Manage employee development activities.
- Responsible for maintaining operational/expense budget, headcount budget, and capital budget for the North America Regulatory Affairs department. Review monthly budget performance.
- Maintain awareness of all regulatory activities and current statuses regarding new and approved drug products. Stay current with state-of-the-art-standards on the regulatory process.
- Interact with other functional areas and executive leadership as needed to provide guidance with respect to regulatory issues.
- Ensure process and resources are in place to allow timely review of internal documentation such as change control information, method transfer packages, batch records documentation, validation protocols, and reports.
- Bachelor's degree (or equivalent), and a minimum of 15 years of experience in Regulatory Affairs is required. Related experience may also be considered.
- 10 years of experience in a Regulatory Affairs leadership role where direct relationships with regulatory authorities were built and/or maintained is required.
- Must possess expert-level knowledge and interpretation of FDA regulations and industry guidances, policies, and procedures pertaining to the submission, approval and post-approval processes.
- Ability to read and interpret comprehensive and intricate research documents. Ability to clearly and succinctly write scientific/regulatory summaries and technical correspondence.
- Previous management experience is required.
If this is something you would be interested in or know someone who might be, please apply to the role directly or alternatively, you can reach out to me at firstname.lastname@example.org for more information.
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