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Team Leader Labeling

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Type of experience requiredLeading a team in the Regulatory Labelling with hands on experience in handling labelling activities for global markets especially, US and Europe in a reputed Pharmaceutical Organisation. ResponsibilitiesFunctions as the labeling lead working with Global product owners and a cross-departmental team to ensure key deliverables.Responsible for timely readiness of labels which includes artworks, and all enclosures for submissions and commercialization.Knowledge and SkillsKnowledge on regulations on labeling for US, Europe is mandatory and preferably for ROW markets.Knowledge on artwork preparation and review.Knowledge on softwares associated with creation of artworksGeneral standards, processes and policies of Pharmaceutical manufacturing IndustryGood oral and written communication skills.Strong project management and strategic problem solving skills.Sound interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities.An assertive, take-charge, proven manager with a strong results orientation, positive can do attitude, and a sense of urgency to get things done. Provides review support and guidance to labeling staff on technical and regulatory knowledge towards preparation of labels as assigned to the team.Responsible for effective coordination and collaboration with cross functional teams across the globe to ensure key submission deliverables.Planning and tracking of various tasks related to labeling including change control initiation and management till completion of submission.Effective planning of resources and management of all the day to day regulatory labeling activities.Responsible for providing adequate support to the Global team for the regulatory process improvement initiatives.Responsible for ensuring compliance of the team to the submission standards, procedures and policies framed by/for Global Regulatory Affairs.Ensures compliance to companys internal procedures and training SOPs (ISOTrain).Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.Makes recommendations for regulatory department operating procedures/ guidelines. May be responsible for creating and reviewing guidelines/ process or SOPs as needed.Actively trains/mentors junior staff.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-12


Regulatory Affairs
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