Regulatory Affairs Executive

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

Job summary

Sarthee Consultancy invites applications for an Executive Regulatory Affairs (RA) role in Navi Mumbai, Maharashtra. The position centers on coordinating DMF submissions and ensuring regulatory readiness across R&D, production, QA/QC, and ADL teams.

You will liaise with marketing and logistics to meet customer requirements, review LOA/CEP before issuing to customers, and manage eCTD amendments. Suitable candidates have 2–4 years of Regulatory Affairs experience and a background in Pharmacy or

Qualifications

• Graduate/Postgraduate in Pharmacy or 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

• Coordination 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 knowledge

LOA/CEP knowledge

eCTD submissions

Education

Graduate / Postgraduate 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