Job Profile Job Description Vice President, Regulatory Affairs Summary: The Vice President, Regulatory Affairs leads the development, implementation, and direction of effective regulatory strategies with oversight for all of quality and compliance for the company’s oncology pharmaceuticals. The position has responsibility for tracking and evaluating governmental and international regulations and their impact relative to drug regulation. The incumbent builds and maintains excellent relationships with the FDA, other health authorities and corporate partners while advocating the company’s position. Recent oncology experience required. Duties and Responsibilities: • Responsible for overseeing the company’s global regulatory and quality strategies and policy development; directs the functional resources related to these areas and provides on-going, hands-on expertise. • Develops and implements comprehensive regulatory strategies for the company’s drug products, i.e., small molecule compounds; oversees the implementation of these policies for earliest possible approvals of Phase I through Phase III applications. • Reviews proposed changes to regulated processes and / or products to identify regulatory implications; provides direction for significant deviation events that may impact compliance status. • Directs the review and provides regulatory guidance on labeling, promotion, and advertising as appropriate. • Ensures compliance with regulatory requirements for submissions; plans and oversees INDs, IMPDs, CTXs, NDAs, CTDs, BLAs, MAAs, Annual Reports, and other regulatory submissions. • Reviews Final Study Reports, Manufacturing Process Documentation, Investigator Brochures, Clinical Study Protocols, and clinical trial documentation for compliance with cGCPs, cGMPs, cGLPs and other appropriate regulations and guidelines. • Manages and provides internal training for FDA, EMEA, ICH guidelines and regulations. • Acts as primary liaison and coordinates meetings with FDA, EMEA, and other regulatory agencies as needed; represents the company with domestic and international (EMEA / EU and ROW) health authorities. • Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance; communicates the company’s position to internal stakeholders and external partners. • Provide organizational leadership for worldwide regulatory and quality professionals. Requirements: • Degree in scientific discipline; advanced degree preferred. • 10 years of experience in the pharmaceutical / biotech industry in all phases of regulatory submissions and interactions as a regulatory professional with several NDA / BLA submissions that include oncology expertise; knowledge of small molecules a plus. • Direct contact and negotiation experience with the FDA, with the ability to provide hands-on support with FDA filings; post-approval and international experience a plus. • Experience in guiding the Quality function and familiarity with GxPs. • Excellent communication skills; team member that can work collaboratively with colleagues across all functions. • Excellent analytical, presentation, and writing skills are required. • Senior managerial experience in a hands-on, small company environment. 1984-2012. 28 Years of Excellence!
$250,000.00 - $270,000.00
Posted on Aug 10,2014
Company info Helffrich International Website:http://www.higlobalsearch.com
Helffrich International, established in 1984, is a 'modified retained' search firm that specializes in sourcing management, sales, marketing and senior level technical professionals for domestic and international positions. The company works primarily for clients in the advanced materials, energy, medical equipment, mining, and manufacturing industries.
Helffrich International is a preferred member of Top Echelon, one of the premier networks of independent search firms in the world. This affiliation provides immediate access to a large, current data base of candidates who meet specific discipline, industry and geographic requirements. It also furnishes information on salaries, incentive programs, benefits, relocation and other forms of compensation used to attract and retain top talent. Helffrich International does not hesitate to partner with search firms around the world when appropriate.
The Principals, Michael D. Helffrich and Alan B. Helffrich Jr. have more than 50 years of combined experience in executive search. Further, they have domestic and international experience as Sales, Branch, Regional and General Manager, Vice President and President of various multinational industrial and financial companies in the United States, Latin America and Europe.
Both Principals are Certified Personnel Consultants. Both have served as Officers of local, state and international business and personnel associations. Both speak several languages and have a global business perspective. This background assures clients a pragmatic, in depth understanding of business operations and the factors affecting senior staffing decisions.
Our strength is identifying, qualifying and recruiting professionals who are not on the market. Further, compared to traditional retained search, our modified retained modus operandi assures better performance at less cost. We have never failed a modified retained search assignment.