Regulatory Affairs Associate

Title Regulatory Affairs 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  Boehringer Ingelheim is currently seeking a talented and innovative Regulatory Affairs Associate to join our Regulatory Affairs department located at our Bedford, OH facility. As a Regulatory Affaris Associate you will be responsible for filing and coordinating regulatory strategies to expedite approval of drug applications in accordance with domestic and foreign agencies. This person also provides counsel to other departments regarding compliance with the conditions of approval and also provides direction in responding to agency requests. They are in regular contacts with others within and outside the organization to obtain, present, or discuss data pertinent to an immediate situation or a specific assignment. Works with other departments to impart knowledge and understanding of regulations (cGMP, cGLP, etc.) for the manufacture of products and works with other departments to gather information needed for submissions.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success.

We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.

Responsibilities:

* Sets priorities in conjunction with other departments to meet deadlines and * communicates (written and verbal) with the FDA on behalf of the Company and customers. * Reviews documentation from other departments for content and appropriateness for use in regulatory submissions.  * Generates applications in accordance with title 21 CFR and all FDA guidelines.  Maintains original documentation, which determines the basis of approval. * Submits all periodic and annual reports associated with approved applications. * Reviews the manufacturing batch records for accuracy and content to support production activities. * Coordinates Stability Program. * Reviews BVL’s and Innovation’s labels for accuracy. * Files ANDAs electronically to the FDA. * May show another employee how to perform tasks, or orient a new employee.

Requirements:

* Requires a minimum of a four-year science-related degree.  * Must posses one of the following: a.) Minimum of one year of Regulatory Affairs experience that includes filing applications to the regulatory agency; b.) Minimum of 3 to 5 years of pharmaceutical manufacturing facility experience preferably in production, quality control, compliance/assurance, R & D, or regulatory affairs; c.) An advanced science-related degree with three years pharmaceutical experience as outlined above. Proficiency in the use of Microsoft Office products including project planning techniques and software. * Must possess excellent written and verbal communication skills. * Must have excellent organizational skills.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V

Requisition ID BV25409 Date Posted 13-Oct-2009

Please refer to job code boehringer-509203 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