Senior Director - Regulatory Affairs
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Ardsley, NY, United States
The Senior Director - Regulatory Affairs is responsible for managing Regulatory Affairs activities (nonclinical and clinical) for assigned investigational and/or marketed products.
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.
*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:
- Bachelor’s degree in Chemistry or Biology or Science related field required.
- Master’s or Ph.D. degree in Chemistry, Biology, or Science related field preferred.
- Minimum of ten years progressive experience in a regulatory affairs position preferred.
- Minimum of 15 years experience in the pharmaceutical or biotechnology industries.
- This individual may supervise associates in the regulatory affairs group.
- Must have demonstrated experience in filing INDs and annual reports in an e-CTD format; a strong knowledge of FDA/ICH regulatory guidelines; excellent verbal and written communication skills; work well with employees across the organization and strong interpersonal skills, and tactful negotiation skills.
- Some knowledge of CMC regulatory guidelines and global drug development is preferred.
- Must be proficient in MS Office Suite.
- Experience with DocCompliance and MedXview or other web-based document management/publishing software for electronic submissions preferred.
Certificate, Licenses, Registrations:
- RAC (US) preferred; RAC (EU) and (CAN) preferred.
Other Skills and Abilities:
- Excellent writing, communication, and presentation skills.
- Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment.
- Strong skills in planning, organizing, decision-making and problem-solving.
- Demonstrated leadership and project management skills.
- Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
- Demonstrated ability to stay abreast of trends and new information.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires travel; the average travel for this position is 10-15% (both domestic and international including overnight) with some variation based upon the demands of the business imperatives.
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
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.