Regulatory Affairs Executive

Sarthee Consultancy; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Sarthee Consultancy is hiring an Executive Regulatory Affairs to operate from Navi Mumbai, handling DMF submissions and LOA/CEP/eCTD deliverables. You will coordinate across R&D, Production and QA/QC to ensure regulatory compliance and timely filings.

The role requires 2–4 years in Regulatory Affairs, with a focus on pharma submissions and customer-facing communication with internal teams.

Qualifications

• Graduate or postgraduate in Pharmacy or Life Sciences or related field.
• 2–4 years of Regulatory Affairs experience (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 and logistics for customer requirement compliance.
• Reply to customer/agency queries promptly and accurately.
• Review documents from internal departments/sites for accuracy.
• Review LOA/CEP before customer issuance to ensure compliance.
• Draft change intimations and track customer feedback effectively.
• Handle DMF amendments in eCTD format and update records.

Skills

Regulatory submissions knowledge

DMF knowledge

LOA/CEP knowledge

eCTD submissions

Education

Graduate / Postgraduate in Pharmacy / Life Sciences or related field

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