For The Candidates

The specific title and breadth of responsibilities for this position will be contingent on the experience level presented by candidates.

This position within the Department of Regulatory Affairs is responsible for successful global regulatory support of biological and drug products for  drugs in development, as well as one marketed product. The immediate focus for the person who assumes this role will be to provide regulatory leadership in the support of NDA activities specifically Risk Evaluation and Mitigation Strategy (REMS), the 120-day Safety Update, and the Advisory Committee preparation activities. Other duties will include regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies, and support for InterMune’s early and late stage clinical development programs, non-clinical development programs, license support and post-marketing activities. The position will hold accountability for the success of interactions and negotiations with regulatory agencies on assigned projects and will manage regulatory activities according to corporate goals and timelines. Additionally, this individual will actively participate in various administrative activities to maintain Regulatory Affairs department as a compliant and highly effective organization.

Position Responsibilities:

Provide regulatory leadership for the following NDA activities: 120-day Safety Update, REMS and Advisory Committee..

Proactively provides strategic regulatory guidance and direction to the organization.

Clearly delineates the recommended “path to approval” for Product Development Teams and actively manages according to development timelines and defined strategies.

Provides strong regulatory leadership and representation / leadership to Product Development Teams.

Accountable for successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects.

Works collaboratively and effectively with internal and external personnel.

Interacts and liaises with corporate partners in order to achieve common goals.

Actively supports risk assessment, project planning and time-line development activities.

Leads internal and external activities with his/her team to ensure the prompt provision of high-quality, “reviewer-friendly” information in accordance with regulatory requirements and development strategies.

Serves as a mentor to the department and responsible for the administrative management and development team as needed.

Applies leadership in establishing operational and quality standards within the department, and takes the necessary steps to ensure training and consistency with department standard operating procedures.

Advises corporate personnel regarding regulatory strategic recommendations, potential areas of concern and new governmental/regulatory developments.

Reports to Vice President, Regulatory Operations

BS/BA or higher in a scientific discipline.

A minimum of 5 years US bio-pharmaceutical experience. At least 3 years experience at a senior regulatory affairs level in a company involved in the development, manufacture, testing and distribution of ethical pharmaceuticals, preferably biological products.

Direct experience in the recent filing and approval of an NDA/BLA is required

Keen understanding of the drug development process is required.

Strong oral and excellent written communication skills.

Solid working knowledge of Good Clinical Practices (GCPs), current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLP).