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Vice President, Regulatory Affairs and Quality
Setren, Smallberg & Associates, Inc.
Location: San Francisco,
11/6/2007 1:13:16 PM
Privately held Biopharmaceutical Company that has five clinical programs entering Phase 1-2 for large disease states. Excellent senior leadership team and top tier VC backers. San Francisco Peninsula based. Opportunity for fast growth.
Vice President, Regulatory Affairs and Quality
The company is seeking to hire an exceptional Vice President, Regulatory Affairs and Quality to join the executive management team and provide leadership for all Regulatory and Quality activities to drive product development programs. The position will lead the Regulatory and Quality function, direct the company’s regulatory activities and initiatives, assure the quality of products and processes, and ensure the highest integrity in regulatory and quality compliance. The Vice President, Regulatory Affairs and Quality will lead strategic teams to strategize product development plans and ensure timely FDA submission and develop relationships with the agency for effective communication and collaboration of product development and clinical plans with the FDA. Experienced candidates in this position should be able to work effectively in a small company environment, build an organization to meet corporate and drug development objectives, and hire a team to effectively support multiple therapeutic programs and teams. Since there are several ongoing clinical programs and in several therapeutic areas, this person must be a dynamic leader with outstanding communication, strategic and collaboration skills, and provide the organization with a vision to be facile and adept at balancing work leading teams. The Vice President, Regulatory Affairs and Quality is responsible for directing the strategy and all interactions with FDA, in addition to lead the efforts for the firm’s clinical and pre-clinical products and must be innovative in designing approval strategies through product development plans.
The Vice President, Regulatory Affairs and Quality will have strong leadership skills and the ability to lead multiple Regulatory initiatives and projects at the same time. As well, the Vice President, Regulatory Affairs and Quality will be able to lead the company’s Quality function and build a team to directly manage the quality needs of the organization through direct hires, consultants and outsourcing.
As the company plans to be developing at least one new clinical IND candidate annually, the Vice President, Regulatory Affairs and Quality must have the capability to maintain a strong relationship with multiple therapeutic areas within the FDA.
The position will report to the company’s Chief Executive Officer.
• Help to direct and set regulatory strategy and approach. Communicate strategy effectively to all departments to ensure timelines.
• Coordinate and structure US and international regulatory filings.
• Review the content and format of all regulatory filings.
• Oversee and coordinate compliance with all federal regulations.
• Act as liaison for FDA formal and informal contacts.
• Maintain an updated regulatory archive.
• Provide leadership as an executive committee member, as well as work in close coordination and effectively support the company’s project teams.
The strongest candidate will have at least 10+ years of industrial experience in all aspects of regulatory affairs in a pharmaceutical or biotechnology environment with an educational background in the life sciences. Candidates must have a proven track record of effective collaboration with the FDA from filing INDs through phase I/II, in particular. Experience with antibodies or infectious disease is a plus. The best candidates will have demonstrated their ability to interact productively and to effectively influence peers, external colleagues and senior management.
Strong candidates will have particular strength and a demonstrated Regulatory track record. They will also demonstrate that they have the leadership ability to manage a small Quality organization. Demonstrate effective interpersonal skills including maturity, creativity and a high energy level. Candidates must also have outstanding leadership, communication, collaboration, presentation and analytical skills demonstrated through a successful track record of building teams and submission approvals.
The company offers an excellent total compensation package including competitive base pay, bonus, excellent benefits and stock options.