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RA Labeling Reviewer US Market Pharma OSD in Hyderabad Location

2.00 to 7.00 Years   Hyderabad   10 Oct, 2019
BVR People Consulting
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Job Title: Regulatory Affairs (Labeling) - US Market Company: Leading Pharmaceutical company. Designation: Reviewer No. of Positions: 6 Division: R&D (OSD) Department: Regulatory Affairs Location: Hyderabad. Qualification: B.Pharma/ M.Pharma Years of Experience: 1 to 7 Years. Interested candidates can reach me through Contact person: Mr. B.Saravana Prabhu call : 7676636384 email: saravana@bvrpc.com whats app: 9790291595. Profile we are looking for:

  • Candidates should have core labeling experience in RA
  • Candidates who are working in consulting firms are not suitable
  • Candidate should have experience in preparation of artworks & pack inserts.
  • Three years of service agreement will be there for candidates with experience of 4 years and below.
Roles & Responsibilities:
  • Development and approval of Artworks including required change management activities.
  • Timely submission of labeling (artworks) with high level of quality and accuracy for new submissions, amendments and supplements.
  • Co-ordinate with cross functional and global teams for ensuring the timely availability and release of approved artworks to meet the commercial requirements.
  • Planning and maintenance of labeling tracker to ensure the availability of approved artworks as per timeline.
  • Complies with all standards, procedures and policies for regulatory labeling submissions set forth for the Regulatory Function.
  • Remains knowledgeable about current regulations and guidance of regulatory labeling to perform day to day regulatory labeling activities.
  • Responsible for ensuring compliance to company submission standards, policies and procedures.
Salary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: PackagingRole Category: Role: Packaging Development Executive/ManagerEmployment Type: Full Time, Permanent , Education:UG -B.Pharma - PharmacyPG - M.Pharma - Pharmacy

Keyskills :
globalteams changemanagement regulatoryaffairs packagingdevelopment set reach pharma planning clinical packaging management commercial consulting compliance regulatory maintenance regulations preparation availability lobalCrossFunctiona

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