Regulatory Affairs Executive

Sarthee Consultancy; Boisar; On-site; INR 600,000 - 900,000; Full time

Job summary

Sarthee Consultancy is seeking an Executive Regulatory Affairs professional in Navi Mumbai, Maharashtra. The role focuses on coordinating DMF submissions and LOA/CEP reviews, ensuring regulatory compliance across R&D, production and logistics.

The ideal candidate has 2–4 years in Regulatory Affairs, with knowledge of eCTD submissions and related regulatory documents, ready to liaise with various internal teams and customers.

Qualifications

• Graduate / Postgraduate in Pharmacy / Life Sciences or related field.
• 2 to 4 years experience in Regulatory Affairs (Pharma industry preferred).
• Knowledge of DMF, LOA/CEP, and eCTD submissions.

Responsibilities

• Coordinate with R&D, Production, QA/QC, and ADL teams for DMF submissions.
• Liaise with marketing & logistics for customer requirement compliance.
• Reply to customer/agency queries.
• Review documents from internal departments/sites.
• Review LOA/CEP before customer issuance.
• Draft change intimations and track customer feedback.
• Handle DMF amendments in eCTD format.

Skills

Regulatory Affairs

DMF

LOA/CEP

eCTD submissions

Pharma industry knowledge

Education

Bachelor's or Master's in Pharmacy / Life Sciences

Job description

We' re Hiring: Executive Regulatory Affairs (RA)

Location: Navi Mumbai, Maharashtra

Department: Regulatory Affairs

Industry: Pharmaceuticals

Qualification Must-Haves

• Graduate / Postgraduate in Pharmacy / Life Sciences or related field
• 2 to 4 years experience in Regulatory Affairs (Pharma industry preferred)
• Knowledge of DMF, LOA/CEP, and eCTD submissions

Key Responsibilities

• Coordinate with R&D, Production, QA/QC, and ADL teams for DMF submissions
• Liaise with marketing & logistics for customer requirement compliance
• Reply to customer/agency queries
• Review documents from internal departments/sites
• Review LOA/CEP before customer issuance
• Draft change intimations and track customer feedback
• Handle DMF amendments in eCTD format