Regulatory Affairs

Greetings from Team Management Services (TMS), an end-to-end HR consulting firm!

Currently we have an urgent job opening for the position of Regulatory Affairs with one of our clients located in Thane Location.

Company Profile:

Our client began in April 2002 from Operations in Mumbai, India, with a diverse portfolio of pharmaceutical and healthcare products catering to global markets. With a clear plan to establish a state-of-the-art manufacturing facility, the company operationalized its first fully integrated manufacturing unit in 2008, complete with an R&D center and a GMP-compliant warehouse. The organization achieved its first milestone accreditation, WHO-GMP (India), in September 2009. In 2006, the company expanded internationally by establishing its first overseas headquarters in the heart of Moscow, Russia, further strengthening its global presence. Today, the organization is dedicated to excellence in manufacturing, research, and the delivery of high-quality healthcare products worldwide.

Position Title:Regulatory Affairs

Qualification: Mpharm/ Bpharm MSc/

Experience: 2+ Years

Location: Thane

Job Responsibilities:

• Preparation & Compilation of the product Dossiers of various pharmaceutical formulations for CIS & ROW Market.
• Review of all technical documents (BMRs, Process Validation, Method of Analysis, and Analytical Method validation, Stability, API, FP, PM COAs & DMF etc.) recd. from Factory & follow-ups with related departments for the same or correction/up gradation in data so as to have better compilation of dossiers.
• Answering Queries related to Drug Product Registration.
• Checking of artworks as per countries requirement.
• Provide Label Claim of New finished product for License application; checking of Lic. , COPP
• Preparation of documents required for BE Studies.
• To co-ordinate with Q.C., Q.A., Purchase, Production & R&D department for preparation of Dossiers of Pharmaceutical formulations.
• Co-ordination with R&D Dept. & Support in New product development by providing all the details of new product to R&D.
• Maintain Update status.

Skill Set:

• Minimum of 2 years of relevant experience in Regulatory Affairs or related fields in the pharmaceutical industry.
• Strong knowledge and hands-on experience in preparing regulatory dossiers, especially for CIS and ROW markets.
• Excellent communication skills in English, both written and verbal.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.).
• Ability to work independently and efficiently under deadlines.
• Attention to detail and problem-solving abilities.

Thank you and hope to talk to you soon in more detail.