Walkin Interview - Baroda (Regulatory Affairs) 13th July

• WALKIN DRIVE - REGULATORY AFFAIRS @ BARODA (FORMULATIONS)

• DATE : SUNDAY, 13TH JULY 2025 || TIME : 9.30 AM

• VENUE : SUN PHARMACEUTICAL INDUSTRIES LIMITED, NEAR AKSHAR CHOWK, SUN PHARMA ROAD, TANDALJA, VADODARA - 390012|

• DEPARTMENT : REGULATORY AFFAIRS - US MARKET | LABELLING | PLANT RA

• EXPERIENCE RANGE : 2-8 YEARS

• GRADE ; EXECUTIVE / SR EXECUTIVE

JD:

FOR US MARKET ;

1) Compilation , review of dossier for US , EU , AU, Canada & IL market (ORALS/NON ORALS)

2) Review of query response prepared and compiled by regulatory associates

3) Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management

FOR LABELING:

1) Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations.

2) Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations

FOR PLANT RA

1. Participates in activities related to new product registration/ new filing, re-registration, sample, queries of regulatory agency and variation filing.

2. Product life cycle management: review the Change control and provide final variation category. And arrange documents for Filing. And Activities related to variation management.

3. Approval package (Emerging Market): Co-ordination with corporate regulatory and plant team for impact analysis of proposed change against approved package and filing of variation whenever applicable

Candidates having above experience can walk-in with their updated resume and relevant documents . Those unable to attend interview may share their cvs to : HR.Tandalja@sunpharma.com

Disclaimer - Sun Pharma does not seek payment of any kind from a prospective candidates for employment with company or authorize any agency or any individual to collect or charge payment for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be part of Sun Pharma.