Regulatory Affairs Executive

Sarthee Consultancy; India; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Sarthee Consultancy is seeking an Executive Regulatory Affairs (RA) professional for its Navi Mumbai operations. The role is within the Regulatory Affairs department of a pharmaceutical-focused organization, requiring collaboration with R&D, Production, QA/QC, and ADL teams to ensure DMF submissions meet customer and regulatory expectations.

Ideal candidates have 2–4 years of Regulatory Affairs experience, with strong knowledge of DMF, LOA/CEP, and eCTD submissions.

Qualifications

• Graduate or postgraduate in Pharmacy, 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 and logistics for customer requirements 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

DMF knowledge

eCTD submissions

Regulatory liaison

Cross-functional coordination

Education

B.Pharm or MSc in 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