Lung Rx, Inc., headquartered in Silver Spring, Maryland, is a start-up biotech company that is
wholly-owned by United Therapeutics, Inc. (NASDAQ-traded biotech company).  Lung Rx, Inc. was
formed in 2004, with the mission of developing innovative medicines to treat lung disease, and
innovative inhalation-based therapies. 

 

This is the most senior position in the company�s Regulatory Affairs section, reporting
directly to the Chief Medical Officer.  The Director, Global Regulatory Affairs will be
responsible for coordinating the company�s worldwide regulatory strategy for its lead product,
as well worldwide regulatory activities associated with the discovery and development of new
products and new indications for existing products.  In addition, the incumbent will be
responsible for leading the work of a growing Regulatory Affairs team.

Responsibilities:
� Provide vision, leadership, and guidance to the entire Regulatory Affairs team.
� Oversee the development and implementation of sound world-wide regulatory objectives,
strategies, and plans for all products in development. 
� Oversee the preparation and submission of all regulatory documentation to health authorities
worldwide. This documentation will include but not be limited to INDs, NDAs, CTAs, MAAs, orphan
drug applications, annual safety update reports and amendments. Manage the assembly and
internal review of these submissions. Assure that all submissions meet the highest regulatory
standards for content and format. Coordinate and consult with other departments on the content,
review and assembly of regulatory documentation
� Develop and implement internal policies and procedures relating to all aspects of the
Regulatory Affairs functions. Assure that company policies and procedures are effective,
efficient, and compliant with all regulatory requirements. 
� Serve as the Regulatory Affairs representative on project teams, providing advice on the
interpretation and application of all relevant regulatory requirements and Guidances, in the
context of the specific project. Ensure that regulatory support is provided to relevant staff
of other departments. Communicate as needed to functional teams and external partners.


EDUCATION AND EXPERIENCE
The successful candidate will be a skilled regulatory professional with a track record of
success in a leadership regulatory affairs position at a biotech/pharmaceutical company.  The
candidate should have extensive knowledge and experience in global regulatory standards,
policies, and procedures.  A minimum of 8 years of regulatory affairs experience is required. 
The candidate will have a Bachelor's degree (or equivalent) in a scientific, health care or
related field with demonstrated leadership and interpersonal skills. An advanced degree is
preferred in Biochemistry, Chemistry or another physical/clinical science or equivalent
education and experience.

Please email your resume to  [email protected] or fax it to 301-608-2643.  EOE
 
 
 
 
 

 
Contact: 
 
 
Company: United Therapeutics Corp 
Address: US-DC-Silver Spring 
Reference Code: Reg Affairs