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.
SUPERVISORY RESPONSIBILITIES:
- This individual may supervise associates in the regulatory
affairs group.
QUALIFICATIONS:
- 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.
COMPUTER SKILLS:
- 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.
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.
- 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.
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
*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.