Senior Director Regulatory Affairs

The Senior Director - Regulatory Affairs is responsible for managing Regulatory Affairs activities (nonclinical and clinical) for assigned investigational and / or marketed products. This individual manages the development of regulatory strategies for development of investigational drugs and post-approval marketed product support; preparation, review (for content and format), and filing of documents to health authorities, in particular investigational new drug applications (INDs) and / or marketing applications (NDAs / MAAs). This individual is expected to be capable of serving as the Regulatory Project Lead for assigned projects, responsible for establishing and implementing regulatory strategy, acting as primary contact with relevant health authorities and representing Regulatory Affairs on the project team.

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ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Develops and implements regulatory strategies to support investigational drug development and filings of INDs and NDAs for assigned products.
• Leads regulatory activities, including planning and reviewing of nonclinical and clinical sections of regulatory submissions for format and content.
• Develops and manages regulatory submission project timelines for assigned projects.
• Coordinates and prepares company responses to information requests from health authorities.
• Acts as the primary company contact to health authorities for assigned investigational drugs and marketed products, including leading meetings with health authorities and business partners.
• Maintains in-depth knowledge / awareness of federal regulations and policies regarding development of investigational agents and maintenance of marketed products to optimize Acorda regulatory strategies.
• Responsible for Regulatory input into product labeling, including coordinating development of product label, utilizing internal or external regulatory labeling resources.
• Supports assigned marketed products with regulatory review of product labeling and advertising materials.
• Maintains and in-depth awareness of relevant federal and international regulations and policies to optimize Acorda’s regulatory strategic input to assigned project teams for investigational and marketed products.
• Undertakes ongoing performance review, feedback and development of staff.
• Assists with talent recruitment and leads a highly motivated, efficient and effective team.
• Responsible for training and mentoring associates on the Regulatory Affairs Team.

EDUCATION AND / OR EXPERIENCE :

SUPERVISORY RESPONSIBILITIES :

QUALIFICATIONS :

COMPUTER SKILLS :

CERTIFICATE, LICENSES, REGISTRATIONS :

OTHER SKILLS AND ABILITIES :

PHYSICAL DEMANDS :

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

WORK ENVIRONMENT :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

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