Executive Director Job Opening - Regulatory Affairs | Princeton - Edison, NJ

Princeton, NJ - Edison, NJ -- Conselium is currently conducting a search for qualified candidates in Princeton and Edison, New Jersey to fill a job opening for an Executive Director, Regulatory Affairs position at a major pharmaceutical producer in the Northeast.


Executive Job Opening - Opportunity Profile:


Our client is a world leader in providing consumers with an extensive line of high-quality, affordable, and effective pharmaceutical products in a variety of traditional and innovative dosage forms. 

 
The Company is the largest producer of generic transdermal pharmaceuticals in the United States.  The Regulatory Affairs Department currently is seeking qualified individuals in Princeton and Edison to fill its opening for an Executive Director.

 
The chosen candidate for this exciting and challenging opening for Executive Director - Regulatory Afairs will report directly to the Vice President of Regulatory Affairs.

 
Responsibilities will include:

• An emphasis on the preparation, review and evaluation of documents for FDA submission.
• Providing regulatory advice and counsel to other functional areas with regard to the regulatory aspects of drug development and marketing.
• Interacting directly with FDA personnel via written correspondence, teleconferences and meetings.

To submit your name and resume to be considered for this executive job opening, send an email to the Compliance Department at Conselium:


compliance@conselium.com

Qualifications for Executive Director Position:

--The successful executive director candidate will possess a B.A. or B.S. degree in science or health-related discipline and 18 years pharmaceutical industry or related experience with 12-15 years experience in a pharmaceutical regulatory affairs environment.

• An M.S. or Pharm.D. degree with a minimum of 16 years pharmaceutical industry or related experience with a minimum of 10 years in pharmaceutical regulatory affairs environment will also be considered for executive director.
• A Ph.D., M.D. or J.D. degree with a focus in science or health related discipline with a minimum of 13 years pharmaceutical industry or related experience with a minimum of 6 years in the pharmaceutical regulatory affairs environment will also be considered for executive director.

--The successful executive director candidate must possess a strong background in the generic drug industry, CMC, development of new drug products with a working and practical knowledge of Federal laws, regulations (21 CFR), guidelines, policies and procedures related to drug development, registration, review and approval, including a solid understanding of the USP, cGMPs, cGCPs, and cGLPs.

--Additionally, this individual must have excellent project management, interpersonal and consensus gathering skills, a strong work ethic and exemplary written and verbal communication skills.

--The successful individual must be well-organized, attentive to detail, even-tempered and capable of providing support and direction to others. Applicable computer skills in a Windows-based environment are also necessary.

About The Company

Our client has an entrepreneurial spirit, where employees are challenged every day to exemplify our vision through their innovation, dedication, and integrity. They attempt to hire the best, and therefore, expect the best.

If you currently work in Princeton or Edison, NJ and are ready to meet this challenge, we invite you to submit your name and resume for consideration.

Our client offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Our client is an Equal Opportunity Employer, M/F/D/V – Taking pride in diversity.

Conselium is a personalized executive search firm that specializes in the area of compliance. Founded in 2001, with offices in Dallas and Houston, Conselium works with executive job candidates in Princeton and Edison, NJ and has become the most respected name for compliance search services in the U.S. Call 972-934-8444 or send us an email:

compliance@conselium.com