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Premium Employer

Aurigene Pharmaceutical Services

Compare

4.1

based on 196 Reviews

16 Aurigene Pharmaceutical Services Jobs

Team Member - Regulatory Affairs

Aurigene Pharmaceutical Services Limited

4.1

based on 196 Reviews

3-8 years

Hyderabad / Secunderabad

1 vacancy

Team Member - Regulatory Affairs

Aurigene Pharmaceutical Services

posted 5mon ago

Job Role Insights

Flexible timing

Key skills for the job

Auditing Regulatory Affairs Packaging Compliance Data Enrichment

Job Description

Educational Background Masters in Science or Pharmacy Exposure 5-10 Years of RA experience or atleast 5 years of cross functional experience and 3 years of RA experience Must have exposure Atleast 1-2 new submissions in US & EU Understanding of eCTD requirements Exposure to eCTD & eCTD validation tools Comprehensive Knowledge on ICH qulaity Guidelines Comprehensive understand on current regulatory requirements like Nitrosamines, Elemental Impurities, Genotoxic Impurities, GDUFA, and NDC,

Organizes and assists in the review of materials for Submission Assembles and maintains regulatory files to support product submissions and assesses the potential impact from new guidance and regulations Researches requirements (local, national, international) and options for regulatory submissions, approval pathways Identifies requirements and potential obstacles for market access and the need for further regulatory guidance. Supports the preparation of dossiers and submission packages for regulatory agencies Provides regulatory input and support and as necessary follow-up for inspections and audits Monitors and participates in the review of change requests to ensure compliance and the potential for regulatory submissions.

Employment Type: Full Time, Permanent

Read full job description

Prepare for Regulatory Affairs roles with real interview advice

People are getting interviews at Aurigene Pharmaceutical Services through

(based on 16 Aurigene Pharmaceutical Services interviews)

Referral

Campus Placement

Walkin

Job Portal

37%

19%

6% candidates got the interview through other sources.

High Confidence

What people at Aurigene Pharmaceutical Services are saying

What Aurigene Pharmaceutical Services employees are saying about work life

based on 196 employees

73%

92%

58%

92%

Flexible timing

Monday to Friday

No travel

Day Shift

View more insights

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Aurigene Pharmaceutical Services Hyderabad / Secunderabad Office Location

View all

Hyderabad / Secunderabad (1)

Hyderabad / Secunderabad, Telangana Office

Bollaram Road, Miyapur, Jaya Prakash Narayan Nagar, Miyapur. Telangana 500049 India Hyderabad / Secunderabad, Telangana
500049