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Vice President, Regulatory Affairs
Chicago, IL
Job Description
Vice President, Regulatory AffairsConsultancy to Full-Time with a Start-UpOur Client is seeking a VP, Regulatory Affairs to support the fast growth of the organization. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, fast moving drug development organization. This position will start out as a Consultancy and quickly move into a full time role. Company is based in San Francisco, CA but the right person for this role can be located anywhere in the U.S. with access to a major airport.Position SummaryThis position will provide regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and cross-functional teams. This person will also oversee our interactions with FDA so it is critical to come to into the role with this experience.To be successful in this role, you must be able to provide sound strategic regulatory guidance, communicate clearly (in verbal and written form), and display exemplary organizational, regulatory and, leadership skills. In addition, the successful candidate will create a successful team culture and build the team over time to deliver exceptional results and ensure long-term success. This role will be focused on Drug Development vs discovery and 505B2 experience is critical.Primary Responsibilities:* Work closely with the executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of company products and product-candidates.* Develop and implement operational plans to achieve board-approved regulatory objectives.* Serve as primary regulatory agency contact (at the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for company.* Serve as key point of contact for managing and directing regulatory inspections.* Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.* Develop and design robust regulatory structures, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.* Partner with and support clinical development, CMC, preclinical, quality, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.* Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.* Provide regulatory review and approval of product labeling, promotional claims, and advertising to ensure compliance with corporate policy, and US laws and regulations.* Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.* Manage internal regulatory procedures to ensure compliance.* Manage external regulatory vendor and platform service team members and providers.* Hire, onboard and manage regulatory professionals as the organization grows.Education/Experience and Skills:* Minimum BA/BS Degree with 15+ years in biologics or pharmaceutical industry experience - prefer knowledge of kidney products, including multi-disciplinary experience, with 10 years regulatory strategy.* Experience in interfacing and responding to relevant regulatory authorities, especially with respect to our products.* Experience working with 505B2 products and bringing them through the FDA submission and approval process is critical.* Thrive in a fast-paced environment combining strategic and tactical capabilities.* Excellent written and verbal communication skills, analytic and problem-solving.* Ability to travel to San Francisco headquarters and other business travel as neededIf you have a proven record of success and the desire to have a positive impact in the healthcare field, we want to hear from you!Company offers a competitive package as a Consultant as well as a robust offering when this position transitions to a Full-Time role. To apply online visit www.impact-bio.com .Our Client is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be considered.
Job Summary
Company
ImpactBio
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
15+ years
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