Vice President Regulatory Affairs
|Job Title:||Vice President Regulatory Affairs|
|Contact Name:||Pavlina Bullaj|
|Job Published:||July 31, 2017 19:21|
Vice President, Regulatory Affairs, NA
East Coast, USA - Virginia
SciPro Global are working closely with a key client based in Virgin who are actively looking for a Vice President Regulatory Affairs. The client is activity looking for a professional with experience in generic/OTC drug submissions. As the VP, Regulatory Affairs you will be responsible for the North American Region, helping to development and implement the regulatory strategy for the United States and Canada across the clients portfolio of generics, brand and OTC products.
Roles & Responsibilities
- Oversight of the day-to-day operations and of the planning, preparation, review and evaluation of documents for submission to the FDA.
- Responsible for ensuring that all regulatory requirements/commitments are met with respect to obtaining approval of new products and maintaining approval for products currently marketed.
- This position provides 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, as well as timely completion of routine regulatory submissions required for maintenance of INDs/CTAs, BLAs, and NDAs/MAAs, such as adverse event reports, annual reports and CMC, nonclinical and clinical amendments to INDs/CTAs, BLAs, and NDAs/MAAs to ensure high quality with an overall objective to receive approval within the shortest timeframes possible.
- Provide strategic regulatory guidance for new and approved products, as needed. Provide input to minimize regulatory issues and help prevent unnecessary regulatory delays.
- 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.
- Responsible for maintaining operational/expense budget, headcount budget, and capital budget for the North America Regulatory Affairs department. Review monthly budget performance.
Education & Previous Experience
- Bachelor's degree (or equivalent), and a minimum of 15 years of experience in Regulatory Affairs. Related experience may also be considered.
- Previous management experience is required, ideally a min of 10 years of experience in a Regulatory Affairs leadership role
- Must possess strong communication, critical thinking and interpersonal skills.
- Must possess expert-level knowledge and interpretation of FDA regulations and industry guidance's, policies, and procedures pertaining to the submission, approval and post-approval processes.
- Must be willing and able to travel domestically up to 20% or as needed.
If this is something you would be interested in, please apply to the role directly or send me an email to firstname.lastname@example.org
I look forward to receiving your application!
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