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4 ProductLife Group Jobs

Group Head of Operations & Transactions

4-5 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Group Head of Operations & Transactions

ProductLife Group

posted 14d ago

Job Role Insights

Fixed timing

Job Description

 
  • Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • To contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Systems Management and Administration
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide regulatory support to clients and associate companies.
  • Liaise with sponsor head-office and affiliate departments on regulatory issues.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub.
Education & Experience
  • University background and/or experience in Regulatory affairs - Module 1 and EU Regulations
  • Bachelor s degree in a science related field
  • 4 to 5 years of experience in Regulatory Affairs
Profile
  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Process orientated with good attention to detail
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • Fluency in English (Spoken and Written)

Employment Type: Full Time, Permanent

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What people at ProductLife Group are saying

What ProductLife Group employees are saying about work life

based on 9 employees
50%
100%
66%
100%
Strict (10.30am - 7pm)
Monday to Friday
No travel
Day Shift
View more insights

ProductLife Group Benefits

Free Transport
Child care
Gymnasium
Cafeteria
Work From Home
Free Food +6 more
View more benefits

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