Regulatory Affairs Officer - Mumbai

We are looking for a highly skilled and experienced Officer Regulatory Affairs to join our team in the Pharmaceutical and Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs and a passion for driving business growth. · Roles and Respons ...

The Regulatory Affairs Manager will provide support to the Regulatory Affairs Manager and assist in independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents registration samples etc for timely registration of the product ...

We are looking for a highly skilled and experienced Regulatory Affairs Officer to join our team at a reputed Pharma Company. · Bachelor's degree in Life Sciences or a related field. · Minimum 5 years of experience in regulatory affairs within the pharma industry. · ...

Independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents registration samples etc for timely registration of products Preparation of Certificate of Analysis COA and other technical documents for Export Maintaining Record ...

· Job Description · • Lead regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. · • Ensure timely and compliant responses to product deficiencies raised by US regulatory authorities, inc ...

We have vacancy in Regulatory Affairs team for an Assistant role based in Mumbai. · ...

We are looking for a highly organized and detail-oriented Office Assistant to join our Regulatory Affairs team in the Pharmaceutical and Life Sciences industry. The ideal candidate will have excellent communication skills and be proficient in regulatory affairs, particularly in t ...

Officer de Asuntos Regulatorios · CDSCO Submissions · GMP & GDP Implementation · ...

We are looking for a highly skilled and experienced professional to join our team as an Officer Regulatory Affairs Assistant Role in the Pharmaceutical and Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs and excellent analytical ski ...

This position involves preparing CEPs/ASMFs from scratch, submitting and maintaining ASMFs/DMFs and CEPs to the EDQM and/or European National Competent Authorities. · Ensure company products comply with relevant regulatory requirements, · ...

Job Responsibilities · Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance · Identify the required d ...

Review, compile and Preparation of original drug master file (DMF)/ ASMF as per GUDFA guidance/EMA guidance in eCTD format for various agencies. · Review, compile and Preparation of Response to Deficiency as received from Agency. · Working on Life Cycle management of DMF includin ...

RESPONSIBILITIES · Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. · Publishing in eCTD format and submission to respective Regulatory Agencies. · Compilation and s ...

Job Title: Senior Manager – Regulatory Affairs (Pharma) · Location: Malad · Experience: 12+ Years · Job Summary: · We are seeking a highly experienced Regulatory Affairs professional with 12+ years of experience in the pharmaceutical industry. The candidate must have strong exper ...

Regulatory Affairs Officer performs daily tasks assisting AGM - Vet. Div., including BDM & Cust. queries to orders, shipment, Regd etc. · ...

Lead regulatory submissions for Inhalation projects for the US market. · ...

We are looking for an Officer - Regulatory Affairs - should have exposure to Semi regulated markets in Finished Formulations. · Dossier Preparation ACTD/CTD/ ECTD Country Specific for ROW market & to ensure error free & timely submissions as per marketing dept. timeline. · ...

Should have exp in Regulated(EU /US) · Pre-approval filings New marketing authorizations · New dossier submissions to regulatory agency · Review technical documents · prepare Type IA /IB/II variations · prepare submissions license variations & renewals · Required Candidate prof ...

This is a full-time role for a Senior Regulatory Officer based in JNPA SEZ Uran. · ...

Preparation of Dossier in CTD ACTD and country specific format. Resolving queries received from various Ministry of Health. Preparation of Technical master file for Medical Device Finalization of Artwork as per Country specific guidelines. · Co-ordination with vendors for DMF and ...