Senior Officer / Executive

3 - 5 Years

Job Description

1. Preparation/review of European Drug Master Files and timely information to customers for changes wrt variation filing.
2. Preparation/review of CEP dossier and revision report.
3. Tracking of all marketing authorization application wrt DCP procedure, MRP procedure and National procedure.
4. Preparation, review and submission of DCGI Application (Form 44), Test license (Form 29) and local license Application for obtaining the manufacturing licenses of APIs.
5. Preparation and review of all agency communication letter e.g. Letter of access, CEP certificates and other declaration letters.
6. Review of all TDPs and DCGI documents.
7. To assist the team in drafting the customer and Agency query response.
8. Support to all team members wrt Regulatory documents, compilation and submissions.
9. Timely submission of documents and response to marketing department for the customer development.

Salary: INR 3,50,000 - 4,50,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance


Employment Type:Permanent Job, Full Time

Key Skills

Desired Candidate Profile

Please refer to the Job description above


UG:B.Pharma - Pharmacy, B.Sc - Any Specialization

PG:MS/M.Sc(Science) - Chemistry, Organic Chemistry, M.Pharma - Pharmacy

Doctorate:Doctorate Not Required

Company Profile

Ind Swift Laboratories Ltd.
Established in 1995 Ind-Swift has fast evolved towards a business model that is focused on deep-rooted domestic presence and leveraged on high-value mature regulated markets along with considerable growth in emerging markets:
* Ind-Swift Laboratories Ltd. (Manufacturer of APIs)
* Ind-Swift Laboratories Inc. (US Subsidiary)
With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. In house capabilities for Development of APIs, Finished Dosage forms, Non-Infringing Process & World Class facilities for Contract Manufacturing are the inherent strengths
Ind-Swift is well placed in both developed and emerging markets. As we take our path forward in the new decade, we are well aware of the challenges that we face now and would encounter, and as a team we are geared up to make Ind-Swift Laboratories a company which gets recognition as a front runner in the Global Pharmaceutical industry.

With expertise in activities ranging from world-class contract research, process development to final production, our infrastructure offers numerous choices for cooperation. We strive to roll out of continent specific R&D programs and production campaigns, which help companies, maximize penetration of markets and garner increased revenues. Our facilities are constantly expanded and upgraded to meet the increasing demands on quality and consistency of supplies. Our manufacturing plants are accredited by international agencies such as US-FDA, TGA, UK-MHRA, UAE besides others. Our customer base has grown exponentially in key regions of the world including Europe, South America and South East Asia besides US. New projects, ventures and strategic alliances have been forged over the years based on mutual trust, reliability and client servicing.
View Contact Details+

Recruiter Name:Mr.Atul Kumar Chaubey

Contact Company:Ind Swift Laboratories Ltd.

Reference Id:ISLL/DB/RA/01 & 02