Regulatory Affairs Consultant
Apply NowCompany: Tata Consultancy Services
Location: Northbrook, IL 60062
Description:
Responsibilities
1. Maintains full understanding of Global electronic submissions publishing requirements (such as New Market registration, Periodic Safety Report, Annual Report, CMC variations, License Renewal & other commitments) and Management of Regulatory information.
2. Supporting the submission manager by performing document e-QC and submission e-QC review to ensure overall submission quality before submitting to FDA
3. Prepare, review, and submit 2253 promotional material submissions for all pharmaceutical prescription drug products to OPDP, utilizing company standards and guidelines, as well as Food and Drug Administration (FDA) regulations to ensure compliance.
4. Process and publish submissions for Subpart H and Subpart E to OPDP.
5. Prepare, review, and publish Advisory comments, correspondences, and TV commercial submissions to OPDP.
6. Create compliance package binders and process 2253s in Veeva Vault PromoMats.
7. Involve in planning and submitting promotional materials to FDA, which affects the distribution of promotional materials in the market
8. Ensure all the promotional materials submitted meet FDA 2253 submission guidelines
9. Review various types of promotional materials for accuracy and compliance with regulatory requirements, as well as notifying deficiencies and inconsistencies.
10. Ensures maintenance of training infrastructure including SOPs, systems access, knowledge repository, training plans and records.
11. Perform Submission publishing activities for the different regions with applicable dossier formats.
12. Performing publishing activities namely, formatting, proofreading, and correction of typographical and inserting the appendix pieces into documents, scanning.
13. Importing the various documents related to the specific eCTD modules and building them into submissions for NDA, sNDA, INDs, NDS, CTAs, RTOR applications within the docubridge , compiled and archived in the Veeva vault.
14. Perform the required activities within established timelines that are of high quality with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes.
Salary Range: $105,000 - $120,000
#LI-DH1
1. Maintains full understanding of Global electronic submissions publishing requirements (such as New Market registration, Periodic Safety Report, Annual Report, CMC variations, License Renewal & other commitments) and Management of Regulatory information.
2. Supporting the submission manager by performing document e-QC and submission e-QC review to ensure overall submission quality before submitting to FDA
3. Prepare, review, and submit 2253 promotional material submissions for all pharmaceutical prescription drug products to OPDP, utilizing company standards and guidelines, as well as Food and Drug Administration (FDA) regulations to ensure compliance.
4. Process and publish submissions for Subpart H and Subpart E to OPDP.
5. Prepare, review, and publish Advisory comments, correspondences, and TV commercial submissions to OPDP.
6. Create compliance package binders and process 2253s in Veeva Vault PromoMats.
7. Involve in planning and submitting promotional materials to FDA, which affects the distribution of promotional materials in the market
8. Ensure all the promotional materials submitted meet FDA 2253 submission guidelines
9. Review various types of promotional materials for accuracy and compliance with regulatory requirements, as well as notifying deficiencies and inconsistencies.
10. Ensures maintenance of training infrastructure including SOPs, systems access, knowledge repository, training plans and records.
11. Perform Submission publishing activities for the different regions with applicable dossier formats.
12. Performing publishing activities namely, formatting, proofreading, and correction of typographical and inserting the appendix pieces into documents, scanning.
13. Importing the various documents related to the specific eCTD modules and building them into submissions for NDA, sNDA, INDs, NDS, CTAs, RTOR applications within the docubridge , compiled and archived in the Veeva vault.
14. Perform the required activities within established timelines that are of high quality with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes.
Salary Range: $105,000 - $120,000
#LI-DH1