Regulatory Affairs Associate

Company Description

About Collabera:

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.

With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.

• Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)
• Collabera listed in GS 100 - recognized for excellence and maturity
• Collabera named among the Top 500 Diversity Owned Businesses
• Collabera listed in GS 100 & ranked among top 10 service providers
• Collabera was ranked:
• 32 in the Top 100 Large Businesses in the U.S
• 18 in Top 500 Diversity Owned Businesses in the U.S
• 3 in the Top 100 Diversity Owned Businesses in New Jersey
• 3 in the Top 100 Privately-held Businesses in New Jersey
• 66th on FinTech 100
• 35th among top private companies in New Jersey
http://www.collabera.com/about_us/accolades.jsp

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Job Description

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

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.

Additional Information

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