Associate Director Regulatory Affairs, Marketed Products

Associate Director, Regulatory Affairs Marketed Products

 

 

 

 

Responsible for the regulatory strategy of assigned marketed products on a global basis to ensure compliance with regulatory guidelines and legal requirements.

The position has the responsibility for the preparation, coordination, and presentation of Regulatory documents for submissions to the Health Authorities for marketed products worldwide in close cooperation with respective global, regional and local Regulatory Affairs (RA) functions. 

Responsible for supporting the regulatory strategy for assigned marketed products without active life cycle management in close cooperation with respective therapeutic area heads, country or regional RA with the Health Authorities, and with Pharma Operations, Medical, Drug Safety and Marketing. Represents worldwide Regulatory Affairs on assigned Global Project Teams and/or Brand Teams. 

Ensures adherence to regulatory guidelines and legal requirements for Marketed Products 

Ensures adequate surveillance of the regulatory environment related to assigned Marketed Products and influences and anticipates changes in this environment globally. 

Responsible for achieving assigned global regulatory affairs project objectives. 

Leads the Regulatory Core Team for assigned projects. 

Responsible for the maintenance of the Regulatory Core documentation for marketed products. This includes all regulatory documents needed to support Maintenance of Marketing Authorizations (MAAs, NDAs, NDSs, etc) for assigned projects in line with current quality requirements, guidelines and priorities.

Requires Ph.D., Pharm D, or MD in life sciences with 8 years industry experience (preferably within development functions) of which 3 years includes relevant RA experience. Or MS degree in life sciences with 10 years industry experience (preferably within development functions) or BS degree in life sciences with 12 years industry experience (preferably within development functions) of which 7 years includes relevant RA experience. 

Requires scientific and technical expertise, including the ability to develop robust regulatory timelines and action plans covering technical and labeling variations as well as line extensions. Knowledge of drug regulations and guidance documents on variations/ drug development in all main countries is required.



Analytical regulatory skills are necessary. The incumbent should have demonstrated originality in problem solving as applied to drug Regulatory issues and have skills and preferably experience dealing with Drug Regulatory Bodies.  

The ability to work within a global team framework and a multi-cultural environment is required. He/she must have well developed project management skills, including interpersonal skills. Good communication skills, verbal and written are imperative.