Job Description:

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.

Apply Now