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Job Details

Experience: 9-12 Years | Salary: 30,00,000-36,00,000 | Opening(s): 1 | Posted Date : 2023-02-22
Hiring For One of the Leading MNC
Designation Manager Regulatory Affairs- Labeling
Job Description
  • Responsible for planning and assigning of work with team members and timely submission of all filings.
  • Responsible for proofreading of pharmaceutical package inserts and labels ensuring accuracy and consistency against content and redline files and able to proofread a variety of labeling for spelling, grammar, design and format consistency. Ability to pay close attention to detail.
  • To liaise with relevant internal departments and external contacts to ensure labeling requirements for submissions are met.
  • Maintains a positive working relationship with global internal stakeholders and business partners.
Desired Profile
  • Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.
  • Proven proficiency with relevant FDA/ICH and other local health authority regulations & guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations
  • Proven effectiveness with stakeholders in the labeling system from content development through commercial supply
  • Must be able to effectively influence peers and others both inside and outside the organization and maintain effective working relationships.
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
  • Excellent written and verbal communication skills.
  • High integrity with respect to maintenance of proprietary, confidential information
Functional Area Regulatory Affairs
Skills Regulatory Affairs, labeling developments
Education B. Pharm, M. Pharm
Location Mumbai
Contact HR
Call on +91-120-358-0000
Reference id 104147