Regulatory Affairs Associate

Core job responsibilities for this position include:

1. Ensure Area & Affiliate users have appropriate access to RSC and LEx for their daily job responsibilities.

a. Create and submit user access forms.

b. Manage QlikView license allocation to ensure users have access as necessary while appropriately managing RA funding resources.

c. Facilitate a review of User Access Lists on an annual basis to clean up user tables. 

2. Ensure that Area & Affiliate users are assigned the appropriate roles in RSC and LEx.

a. Add/Modify Affiliate Regulatory Managers in RSC as personnel change and as new products are launched in new markets.

b. Add/Modify Affiliate Regulatory Contacts in Launch Excellence as personnel change and as new products are launched in new markets.

c. Update RSC Rosters for notifications based on requests from Area & Affiliate users.

d. Request and post RSC Roster lists on a monthly basis to ensure most up-to-date information is available to users.

3. Monitor Area & Affiliate Systems Support mailbox (??) to provide Level 1 support to users regarding RSC and LEx.

4. Manage change requests submitted by users to help facilitate discussions on future releases of Launch Excellence.

5. Support cross-functional team meetings on Launch Excellence by documenting and posting meeting minutes and drafting presentation material as requested.

6. Map submission and approval information received via RSC to records in Launch Excellence for updates.

7. Create RSC records for distribution of CCDS Updates and other centrally managed product changes.

8. Generate monthly reports for management on Launch Excellence activity.

9. Review user issue logs and make recommendations for additional training sessions or materials to help support users.

10. Support other activities as necessary to ensure successful utilization of RSC and Launch Excellence for Area & Affiliate

Qualifications/ Minimum Education:

Bachelor’s degree in a life science, clinical research studies or information technology required. Degree in chemistry, biological science, or pharmacy preferred.

Minimum Experience/ Training Required:

Minimum of 1-3 years previous regulatory affairs experience preferred. Experience with regulatory submissions in international markets, especially emerging markets preferred. 5 or more years experience in the pharmaceutical industry in one of the following areas (R&D, Manufacturing Operations, Quality Assurance, Regulatory Affairs and/ or Clinical) required.

All your information will be kept confidential according to EEO guidelines.