Director of Regulatory Affairs

Description

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DIRECTOR OF REGULATORY AFFAIRS

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River’s Edge Pharmaceuticals, LLC is a privately funded pharmaceutical company supported by a strong team of experienced pharmaceutical executives. We are a fast growing company that continues to grow each year in double digits. Our office is located in the Johns Creek area of Suwanee, a northeastern suburb of Atlanta, Georgia. Our company has a high energy atmosphere and is a rewarding place to work.
 
River’s Edge Pharmaceuticals, LLC is a high energy pharmaceutical company searching for a Director of Regulatory Affairs in our Suwanee Georgia office to join our growing team of pharmaceutical professionals.
 
Job Description: The River’s Edge Director of Regulatory Affairs will coordinate all regulatory policies and activities in the areas of pharmaceutical quality, compliance, distribution, licensing, and development. This position will require a diverse regulatory background and the ability to access multiple resources to answer regulatory questions and navigate a complex regulatory environment. In addition, this associate will interact with government agencies and consultants to aid in the development of abbreviated new drug applications (ANDA), 505(b)(2) and 510k submissions.

Responsibilities & Duties: 
 

• Manage the aggressive corporate ANDA and 505(b)(2) programs.
• Manage and select outsourced contract research organizations (CRO’s) and Contract Manufacturing Organizations (CMO’s).
• Represent River’s Edge at GPhA, and other conferences as required.
• Represent River’s Edge with the FDA, DEA or other government agencies as required.
• Aid the senior management team in the growth and development of the company.
• Understand pertinent FDA and DEA regulatory issues in regards to prescription product manufacturing, packaging and marketing.
• Manage new drug development program.
• Approve printed material for prescription pharmaceutical products.

In addition to base salary, the company provides generous benefits including health insurance, dental insurance, paid vacation, and 401(k).

Requirements

 

• Degree from an accredited four year university, advanced degree is preferred, but not required
• 5 or more years direct work experience in a regulatory capacity for a prescription pharmaceutical company
• Previous experience with abbreviated new drug applications (ANDA) or new drug applications (NDA)
• Previous experience working with the FDA/DEA desired.
• Prior experience overseeing clinical trials for the development of new drugs
• Knowledge of the contract research organization (CRO’s) industry and Contract Manufacturing Organizations (CMO’s)
• Exceptional organization skills
• Experience working both independently and in team-oriented, collaborative environment is essential.
• Ability to conform to shifting priorities for project timelines and deadlines
• Ability to elicit cooperation from a wide variety of sources
• Strong interpersonal skills
• Positive attitude with a willingness to contribute to the company’s success at any level.
• Able to learn, understand and apply new technologies

Work Conditions:
 
River’s Edge is a team oriented work environment with a positive energy and a growing work force. Typical work hours are 8:30 to 5:30 Monday through Friday. However, extended hours may be required to meet project goals or time lines. This position will require a minimum of travel (less than 15%) but occasional overnight trips may be required.