At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Description:
The Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities.
Essential Functions:
Compilation of regulatory submissions including INDs, NDAs, amendments and supplements and manage submission timelines.
Mantain regulatory information system, including archiving, deliverables calendar. Track recurring regulatory activities, develop and manage submission roadmaps
Cross functional meeting management, including creation and distribution of agenda and meeting minutes
Routine monitoring of regulatory intelligence
Manage clinicaltrials.gov database
Additional Responsibilities:
Backup eCTD publishing
Special regulatory research projects as needed
Education:
Bachelors Degree (BA/BS) Science - Required
Master Degree (MS/MA) Regulatory Affairs or Science - Preferred
Experience:
3 years or more in Pharmaceuticals Regulatory
Skills:
Strong written and verbal communication skills - Intermediate
Team player, able to collaborate cross-functionally across levels and countries - Intermediate
Strong time management, organizational, and planning skills - Intermediate
Ability to multi-task, and to adjust priorities as needed. - Intermediate
Ability to work independently with a minimum of supervision - Intermediate
Strong problem solving skills and analytical ability - Intermediate
Specialized Knowledge:
Experience in MS Word, Excel, Outlook, Powerpoint, and Adobe Acrobat . eCTD and publishing experience preferred
Licenses:
RAC-1 1/2 Yrs-Preferred
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity