NewLink Genetics Corp. a biopharmaceutical company in Ames Iowa, developing new therapeutic alternatives for cancer patients, is seeking an experienced Regulatory Affairs Director. NewLink remains steadfast in its primary focus to take novel treatments and diagnostics through the clinical trials process and bringing products to market.
Responsibilities:

• Direct the regulatory operations and activities of all functions, providing strategic direction and definition. Directs, assists, and executes the production of high quality written deliverables and proactively develops regulatory strategies for the company. Maintains up-to-date knowledge base for all pertinent US and International regulations.
• Assesses regulatory requirements for preclinical and clinical submissions and programs to assure that all development activities are in compliance with applicable regulations and guidelines.
• Drafting, reviewing and administering regulatory strategy and policy throughout the drug development process. Expectations will be to effectively negotiate with regulatory authorities. The incumbent will ensure that the quality and content of submissions will lead to successful and timely approval of regulatory application.
• Plans, prepares and manages timelines for all regulatory submissions including initial INDs, IND maintenance, orphan designations, FDA meetings, etc. Works to develop regulatory strategy to move products to approval as quickly as possible while remaining in compliance with applicable regulations and guidelines and advise on strategies necessary to optimize drug development programs.
• Contribute to the development of biopharmaceutical products by managing the company’s product submission and ensure compliance with local, state, federal and international laws, guidelines and regulations. Supplies expertise internally to ensure compliance with US regulatory requirements 
• Responsible for FDA regulatory contacts and submissions, including  INDs, Adverse Drug Responses (ADRs), IND maintenance, periodic reporting. Responsible for implementation of regulatory strategies designed to obtain rapid government agency review and approval of the Corporation's products and projects.
• Responsible for assuring the regulatory integrity of assigned products. Assesses the accuracy and appropriateness of all submissions to the FDA and other health authorities. Coordinate all meetings with the FDA and other health authorities where applicable. Serves as the primary contact between the company and the FDA, interacting with FDA officials up to the level of primary reviewers. 
• Oversee regulatory operations and strategic aspects of assigned products, including the preparation and submission of correspondence and applications to regulatory agencies. Act as direct liaison with FDA to facilitate the prompt review and approval of applications
• Participate in a quality systems group responsible for short and long-term Quality Assurance systems at all operating locations, consistent with FDA and other regulatory agencies requirements. Develop close working relationships with appropriate FDA officials.
• Defines schedules and work plans for managing monitoring, compiling and submitting FDA filings of high quality standards. Delegates tasks and allocates resources to various projects and provide regulatory affairs direction to Team members, contractors and vendors.

Minimum Qualification

• Bachelor’s degree in business, operations, engineering and related field.  Post graduate training a preferred plus.
• At least 10 years of experience working in biopharmaceutical regulatory affairs is highly desired
• Experience working in a team environment with all levels of employees
• A track record of successful submissions is required
• Strong statistical analysis skills preferred
• Ability to analyze data with statistical programs and prepare documents
• Ability to work independently, as well as within a team
• Occasionally required to travel

We offer an attractive compensation and benefits package with a generous PTO package, flexible work schedule, stimulating work opportunities and a supportive, diverse and friendly working environment.
Resumes along with salary history should be e-mailed to apply@linkp.com mailed to NewLink Genetics 2901 South Loop Drive Ames, IA 50010, Suite 3900 or faxed to 515-296-5557.