Regulatory Consultant

Location - Kharghar, Mumbai

Shift time - 09:00 am to 05:30pm

Working Days - 5

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.

Job Type: Full-time

Pay: ₹600,000.00 - ₹1,000,000.00 per year

Benefits:

• Health insurance
• Paid sick time

Application Question(s):

• This position is for Khargar, Mumbai Location. will you be comfortable?
• Do you have prior experience in drafting regulatory dossiers?

Experience:

• Total: 4 years (Preferred)
• Regulatory Dossier: 4 years (Preferred)
• ICH: 4 years (Preferred)

Work Location: In person