The selected candidate will play a crucial role in ensuring company compliance with all Regulatory Affairs guidelines. This position demands a proactive individual capable of managing critical documentation and stakeholder communication.
Key Responsibilities:
- Demonstrate a strong understanding and good exposure of Regulatory Affairs guidelines set by Indian and international health authorities.
- Handle and respond effectively to customers queries and MOH queries (Ministry of Health) with precision and professionalism.
- Utilize good experience in preparing, compiling, and reviewing critical submission dossiers.
- Expertly manage the end-to-end process for CTD (Common Technical Document), ACTD (ASEAN Common Technical Document), and eCTD (electronic Common Technical Document) dossiers.
Required Experience, Skills, and Qualifications
- Experience: A minimum of 3+ years of relevant experience in a Regulatory Affairs role within the pharmaceutical sector.
- Education: Science Graduate. A B.Pharm degree is preferred.
- Technical Skills: Proven, hands-on experience with ACTD, CTD, and E-CTD dossier formats is essential.
- Soft Skills: Possess good communication skills, both written and verbal, to interact with customers and regulatory bodies effectively.
- Attributes: Detail-oriented, analytical, and able to work in a deadline-driven environment.
About VHB Medi Sciences Limited
VHB Medi Sciences Limited is part of the VHB Group, a well-established and trusted conglomerate with a significant presence in the pharmaceutical and lifesciences sectors. The company is known for its commitment to quality, innovation, and compliance. Working with VHB Medi Sciences offers a stable career path and the opportunity to work on challenging regulatory submissions in a supportive environment.
How to Apply for this Regulatory Affairs Position
Interested and eligible candidates who meet the required experience and qualifications are encouraged to apply.
Please send your updated CV/Resume to the following email address:
Email: nisha.ram@vhbgroup.com
Job Location: Kandivali (Charkop), Mumbai, Maharashtra.
