Manager, Sr. Manager, Regulatory Affairs

This pharmaceutical professional will provide regulatory advice guidance primarily related to regulations  guidances and industry incentives  governing the approval  labeling  and marketing of drug products to various constituencies within the company  including media materials review  sales force training and detailing materials  responsible for tracking and submitting all promotional materials to DDMAC or APLB as required by regulations  Essential Duties and Responsibilities of the position include but are not limited to    Primary contact with FDA for all regulatory promotional matters concerning products    Facilitate the development  review  and approval of promotional materials and marketing activities to ensure compliance with FDA regulations  guidance documents consistency with internal corporate policies    Maintain current knowledge of PhRMA codes  OIG and AMA guidelines    Represent Regulatory Affairs and provide active participation in the Copy Clearance Committee  CCC  process by working with Legal  Medical  Marketing  and Commercial Operations to assure timely review of promotional materials    Collaborate with the Brand teams and provide Regulatory input for all promotional  disease state  non branded  and sales training materials for Marketed  promoted  products  suggesting revisions to minimize regulatory risk while meeting the business needs    Ensure complete  accurate  and timely submission of promotional materials to FDA  by the dissemination or use date  in accordance with applicable regulations    Interact with Sales Training with respect to the development  review  and approval of field training materials    Monitor the regulatory environment to maintain expertise in regulatory principles  new issues  competitive products  and implications for King Pharmaceuticals  Inc    Maintain awareness of competitor activities and proactively monitor the regulatory environment for the assigned product teams  Draft complaint letters to FDA when deemed appropriate    Provide Regulatory input for all Medical Education materials for Marketed and pipeline products through representation on NPRC    Training and mentor other skill center members    Participate in the creation and continuous improvement of overall  best practices  and sharing of experiences with Regulatory Team  Essential Skills BS MS in chemistry  biology  pharmacy or related field and four to eight years of relevant experience in regulatory affairs or equivalent combination of education and experience is required for this position  The successful candidate must have a thorough knowledge of pharmaceutical regulations and associated guidances relating to the advertising and promotion of pharmaceutical drug products  Basic understanding of FDA rules and regulations regarding drug approval  DEA regulations concerning the use of controlled raw materials and distribution of controlled finished products  procedures for assigning NDC s  FDA procedures for drug listing  Back to top

Please refer to job code NJS09-24 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Bridgewater, NJ
County:	Somerset County
ZIP Code:	08807
Pay Rate:	Open
Job Terms:	full time
Company:	King Pharmaceuticals
Phone:	email only please
Fax:	email only please