Regulatory Consultant

Position Regulatory

Company Information

Regulatory Consultant

Role & Responsibilities

The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following:

• Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (EU,US, UK & Australia) and Emerging markets
• Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs
• Providing strategic input to the Management and Partners on regulatory projects
• Keep abreast of new developments in regulations across all critical health authorities

Experience & Qualifications

• Regulatory affairs experience in small molecules for a minimum of

  6-8 years

  is mandatory
• Must be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, Australia/ UK).
• Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules in US/ EU/Australia/ UK
• Computer and technical skills (including eCTD software knowledge)
• Strong & Flawless communication skills.
• Accuracy and attention to detail.

Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated resume to sudhirvinayak@gmail.com

In case of a query, please feel free to speak to the undersigned:

Sudhir Vinayak,

Director, Pharma Placements Inc.

Mobile: 98202 34987