Sagar Daitkar M. Pharm

Regulatory Affairs Associate @Tata Consultancy Services

Mumbai, IN

To review the promotional labeling and advertising materials for Human Prescription Drugs, regardless of the format, manner, or medium by which they are presented. To Provide Regulatory Submissions in Electronic and Non-Electronic Format of the Promotional Labeling and Advertising Materials for Human Prescription Drugs. Possesses strong knowledge and provides support throughout the entire MLR (Medical, Legal, and Regulatory) review process. Office of Promotion and Advertising Review(OPDP)/Advertising and Promotional Labeling Branch (APLB), including complex regulatory questions and submissions for advisory comment. Ensure all relevant communications are thoroughly reviewed and approved using the online review system by Veeva Vault PromoMats. Verifies that materials are assigned to the correct review path, rejects incomplete or unready submissions, and facilitates and documents discussions during live meetings. Review promotional materials during the MLR process to ensure they meet regulatory requirements before being submitted to OPAR via the FDA 2253. Responsibilities include ensuring that materials adhere to FDA regulations, legal standards, and medical accuracy. Demonstrated knowledge of FDA regulations relating to advertising and promotion of prescription products. Product labeling for FDA 2253 submissions like USPI, USMG, USPPI & IFU. To prepare Pre and Post Promotional Materials submissions in Veeva Vault PromoMats and responsible for Submission activities. Create SPARS request in Appian for Promotional Material submissions. To Perform activities according to SOP, guidelines, and procedures. To prepare/ compile FDA 2253 labeling submissions (OPDP) and (APLB) with promotional materials from Mod.1 and submit to using tools like Veeva Vault PromoMats. Responsible for submission publishing activity on US Submissions. To perform QC, internal quality reviews, and comments. Mentoring for new associates. Good process management.

Savitribai Phule Pune University

Master of Pharmacy

Shree Gurudatt Shikshan Sanstha's Loknete Dr. J. D. Pawar College of Pharmacy Manur Tal. Kalwan Dist. Nashik

Bachelor of Pharmacy - B Pharm Medicine

Janata Vidhyalay And Junior College Meshi Tal. Deola Dist. Nashik Pin code. 423102

Secondary Education

CLINI INDIA Academy for Clinical Research & Management, Pune

ADVANCE PROGRAM IN CLINICAL RESEARCH AND MANAGEMENT

Karmveer Ramraoji Aher Art Science and Commerce College Deola Tal. Deola Dist. Nashik Pin code. 423102

Higher Secondary Education (science)

Sandip University

Doctor of Philosophy - PhD