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Vice President, Regulatory Affairs

Posted By:
Kate Higgins
Posting ID:
Mountain View, Ca
 regulatory   affairs 
Category:Biotech / Science
Listing Type:Job
Employment:Full Time
Company:VIVUS, Inc

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VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually. We currently have opening for a Vice President, Regulatory Affairs in our corporate headquarters in Mountain View, CA.

The Vice President, Regulatory Affairs will fulfill the most senior executive role responsible for leading and directing the overall regulatory affairs function for the company and is a key participant within the senior management team for the successful strategic regulatory direction of the company. This position will plan and execute the regulatory strategies for Company products in development; oversee the strategies for addressing the regulatory requirements necessary for the promotion and sales of the companys approved products; ensure compliance with all sales, marketing and medical affairs materials for DDMAC compliance. In addition, the Vice President, Regulatory Affairs will be responsible for the analysis and evaluation of regulations and provides expertise in translating regulatory requirements into practical, workable plans in the US and worldwide and will oversee the evaluation and analysis of the impact of trends relative to government regulatory agencies; oversee timely preparation of organized and scientifically valid submissions.


- Participates as an active member of the senior management team to ensure the strategy and vision of regulatory affairs is in constant support of the strategic development vision of the company.
- Will design, implement and control procedures to review all external materials for compliance with DDMAC regulations
- Be the Chief compliance officer for local, state and federal filing and reporting requirements
- Oversees, manages and implements the preparation of major regulatory filings, including U.S. IND, NDA and 510(k) submissions, as well as international dossiers.
- Ensures timely completion of routine regulatory submissions required for maintenance of INDs and NDAs, such as adverse event reports, drug advertising, and annual reports.
- Provides regulatory expertise to development project teams, developing regulatory strategy and execution of strategic plans that are in support of corporate goals and timelines.
- Assumes a key leadership role to provide regulatory guidance to development, marketing and operations groups.
- Reviews technical reports prepared in support of regulatory filings.
- Functions as a liaison to the clinical research unit in support of domestic and international clinical trials.
- Maintains close working relationship with R&D, operations and marketing staff.


- PhD in a scientific discipline.
- Ten to fifteen years of direct, industry-related regulatory experience in pharmaceuticals, biopharmaceuticals or biotechnology industries. Solid regulatory filing experience in either drugs or biologics.
- Involvement in pharmaceutical product launch
- International filing and compliance experience a plus
- At least 5 years experience in a senior regulatory role with previously demonstrated success in project management experience.
- Extensive experience interfacing with regulatory agencies.
- Comprehensive knowledge of current FDA regulations and guidelines with experience in the preparation of IND and NDA submissions for drug products.
- Solid working knowledge of good manufacturing practices, US pharmaceutical regulations, good clinical practices and good laboratory practices.
- Effective verbal and written communication skills.
- Excellent team interaction skills along with demonstrated ability to work on a cross-functional team and influence the decisions of a team.
- Demonstrated abilities to change the thinking of and gain acceptance of others in sensitive situations.

Please submit your resume, with salary history and salary requirements.

Only candidates meeting this criteria will be considered.


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