Regulatory Affairs Senior Associate

Title Regulatory Affairs Senior Associate Department Regulatory Compliance Job Type Full Time Job Category Biotechnology and Pharmaceutical Functional Unit Ben Venue Location Ohio-Cleveland City Bedford Our Culture In a world where business is driven by short term financial goals, Ben Venue Laboratories is truly a company with a different philosophy. As a Boehringer Ingelheim Company, one of the largest and fastest growing pharmaceutical companies in the world, we have been able to maintain a dedication to our values. Our focus is on helping patients, serving our customers and improving the quality of life for the millions of people who rely on us. Simply put, we have remained committed to doing the right thing for our customers, our communities, our employees and everyone we serve. At Ben Venue Laboratories, we realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to create a healthy working environment, meaningful work, diversity, mobility, networking and work-life balance. Ben Venue Laboratories is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, as well as our partners and customers. As part of that commitment, Ben Venue Laboratories conducts pre-employment background checks and drug screenings and is an equal opportunity employer. M/F/D/V. Job Description DUTIES AND RESPONSIBILITIES:

*  Coordinate the compilation of documents needed to file an ANDA/NDA with the FDA and obtain approval. This includes obtaining information from many departments as well review and approval of specifications, test methods, stability protocols, and batch records. *  Respond to any and all deficiencies received on an application through out the course of approval and post-approval within the designated timelines. *  File post-approval supplements to an application as needed due to changes in Chemistry and Manufacturing Controls, labeling, etc.. Must evaluate the change for the appropriate notification route to the FDA. *  Fulfill post approval requirements by submitting annual reports and periodic adverse event reports to an application within the mandated timeframes. Departmental responsibility to place necessary batches on stability to meet annual obligations and acquire data under special circumstances. *  Coordinate theBedfordinternational project from a regulatory perspective. Includes preparing documents and data for submission to foreign regulatory agencies and third party contacts, and coordinating an agreeable timeline for completion.  *  Resolve any deficiencies and questions from international agencies regardingBedfordproducts, including document preparation and coordinating the completion of any special testing requests. Generate international specifications and protocols as necessary. *  Communicate with relevant DMF holders concerning the specifications for the drug substance and any manufacturing changes or updates. *  Ensure compliance with submitted and/or approved information on both the Bedford U.S. products and international products. *  Advise contract customers on regulatory decisions involving Ben Venue as needed. Prepare regulatory documents for contract customers, including NDAs and supplements if necessary. *  Capable of developing a regulatory strategy which is acceptable from both a regulation and business focus for post approval changes. *  Review and ensure compliance with current FDA and International guidelines, as well as compendial standards and supplements.  *  Other job duties as assigned. REQUIREMENTS:

*  Requires a minimum of a four-year science-related degree. Must demonstrate analytical thinking and organizational skills. *  Requires a minimum of four years of Regulatory Affairs experience that includes filing applications to the regulatory agency;. Must have proficient computer skills in word-processing, spreadsheets, and databases (preferred Microsoft Word, Access, Excel, Outlook and Mfg-Pro). *  Requires significant motor ability for keyboarding. Keyboarding is not the complete focus of the position and speed is not a primary requirement, but these tasks take up a significant portion of the work period. Accuracy is essential. *  Requires the performance of duties which are non-standardized. Makes decisions within accepted standards of the profession after reasonable analysis. Often must sort through conflicting data and select between two or three alternatives. *  May show another employee how to perform tasks, or orient a new employee. *  Does not supervise. *  Works regularly with information that is considered restricted and would result in moderately serious consequences either inside or outside the organization if disclosed. *  Have regular contacts with others within and outside the organization to provide information or present the department’s view on an issue. May present data or make recommendations; is required to elicit cooperation of others through contacts governed by normal policies. *  Probable errors would cause serious delays, confusion or expense. Nature of the work includes the opportunity for committing errors of importance. Probable errors likely to affect operations of other departments. *  Position requires uniform mental attention. May require occasional high-speed periods to meet deadlines or handle emergencies. *  The duties of this position typically do not require the incumbent to exert physical effort. *  Works regularly under desirable conditions with few or no disagreeable conditions.

Requisition ID BV09909 Date Posted 25-Mar-2009

Please refer to job code boehringer-493512 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Cleveland, OH
County:	Cuyahoga County
ZIP Code:	44101
Pay Rate:	Open
Job Terms:	full time
Company:	Boehringer Ingelheim
Phone:	email only please
Fax:	email only please