Regulatory Affairs Executive

Sarthee Consultancy; Gurugram District; On-site; INR 500,000 - 800,000; Full time

Job summary

Sarthee Consultancy is seeking an Executive Regulatory Affairs role for a pharma client in Navi Mumbai, Maharashtra. The position centers on DMF submissions, LOA/CEP management, and eCTD activities to ensure regulatory compliance across products.

You will coordinate with R&D, Production, QA/QC and supply chain teams, review documents, respond to customer/agency queries, and draft change intimations while tracking feedback to support regulatory filings.

Qualifications

• Graduate or postgraduate in Pharmacy or Life Sciences or related field.
• 2–4 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 knowledge

eCTD familiarity

LOA/CEP knowledge

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