{"@context":"https://schema.org","@type":"JobPosting","title":"Regulatory Affairs Officer / Sr. Officer / Executive - Fort ( Mumbai )","description":"

Role & responsibilities

1. Dossier Preparation CTD/ACTD/ ECTD and Country Specific format for ROW market & to ensure error free & timely submissions as per provided timelines.
2. To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.

3. To file post approval variations to regulatory agencies for registered products as per variation guidelines.
4. To review technical documents like process validation, AMV, Stability, PDR and CDP etc. received from Site QA or R&D against Dossier requirements.
5. To Coordinate with respective dept. in HO /Plant / R&D for documents & samples required for dossier / registration purpose.
5. Development of New Artworks and Checking for registration and commercial purpose as per regulatory requirement.
6. To Maintain & Update regulatory database for all Manufacturing, Quality documentation, Dossier files, Registrations and RLD samples.

7. Application and checking of administrative documents like Product permissions, COPPs and FSCs.

Preferred candidate profile

QUALIFICATION M. Pharm / B. Pharm

Min Experience : Minimum 2 years in regulatory affairs

Must have handled ROW Market and must have experience of dossier preparation.

Share profiles - rparab@encoregroup.net

","datePosted":"2026-07-02T00:00:00.000Z","validThrough":"2026-08-31T00:00:00.000Z","employmentType":"FULL_TIME","identifier":{"@type":"PropertyValue","name":"myjobb-ai","value":"4627615"},"url":"https://myjobb.ai/jobs/regulatory-affairs-officer-sr-officer-executive-fort-mumbai/4627615","directApply":false,"hiringOrganization":{"@type":"Organization","name":"Encore Healthcare Pvt.Ltd","logo":"https://static.ambitionbox.com/assets/v2/images/rs:fit:200:200:false:false/aHR0cHM6Ly9tZWRpYS5uYXVrcmkuY29tL21lZGlhL2FiY29tcGxvZ28vZW5jb3JlLWhlYWx0aGNhcmUuanBn.webp","sameAs":"http://www.encorehealthcare.in/"},"jobLocation":[{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Mumbai","addressRegion":"Maharashtra","addressCountry":"India"}}],"baseSalary":{"@type":"MonetaryAmount","currency":"INR","value":{"@type":"QuantitativeValue","minValue":250000,"maxValue":350000,"unitText":"YEAR"}}}