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Ra Assoc. Director/ Director - Promotional - DDMAC - Pharm
PA
Type: Full-Time
Category: Regulatory Affairs
Job ID: 832
Opportunity Description:
(610) Area code                                                                       Phili. area
 
Promotional Regulatory Affairs Associate Director
 
We are  a specialty pharmaceutical company focused on high-value branded products and specialty generics. Our portfolio contains products in pain, urology, endocrinology and oncology. We are a customer-centric organization that considers the needs of patients, healthcare providers and the development of our employees, in all actions. We believe in making a difference, and the dedication and experience of our people guide that aspiration. Both our company and the growth of our individuals are driven by a common purpose – to deliver therapies that make a significant, positive impact on patients' lives.

To support our growth, we are currently seeking a Promotional Regulatory Affairs Associate Director to join our Regulatory Affairs team at our  PA Corporate Headquarters.

Reporting to the Director, Promotional Regulatory Affairs (PRA), the Associate Director has primary responsibility for regulatory review and approval of advertising and promotion materials and sales training materials for assigned product(s). Also supports various strategic initiatives to improve our promotional regulatory compliance. Collaborates with the Brand teams during development of marketing campaigns for new products/new indications. Serves as the primary Regulatory Liaison to the Marketing, Managed Markets, Sales, Sales Training, and Marketing Services groups for assigned products. Monitors Drug Marketing Advertising and Communications (DDMAC) activities and actions, assesses impact, and communicates that information on an ongoing, company-wide basis

Req.

BS in life sciences, advanced degree strongly preferred • 7-10 years experience in a Regulatory Affairs including a minimum of 5 years experience conducting regulatory review or managing review of advertising and promotion material preferred. • Understanding of regulatory issues and requirements; knowledge of advertising and promotion regulations, guidances, agency regulatory action history and product labeling requirements

 

 

 
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