Posted by Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Executive Regulatory Affairs & Packaging
Job Description:
Preparation, review and collation of documents of application for Import of New Drugs and Established Products
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
Applicable knowledge of D&C Act, NDPS Act, Legal Metrology Rules etc.
Preparation of additional information or responses as requested by regulatory agencies
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Preparation, review and collation of documents pertaining to application for following certifications: WHO-COPP, GMP, GLP, No Conviction Certificate, Manufacturing & Marketing Certificate, Performance Certificate, Import and Marketing Certificate, Market Standing Certificate.
Management of Testing of Samples at private and government laboratories such as CDTL, NIB, IPC.
Co-ordination with EM sites for P2P and Loan License products with respect to grant of fresh and renewal of licenses.
Conversant with eSugam portal of CDSCO/DCGI and XLN portal of various state FDA.
Other responsibilities as assigned which covers to review and retrieve data from Public Domain.
Maintenance of Tracker of all various activities, status of submissions and approvals
Packaging (Good to have):
Qualifications
B. Pharm, M. Pharm, M.Sc. (Chemistry)
Preferred having: Diploma in Packaging, Diploma in Regulatory Affairs
Experience and Skills:
Responsible for effective interaction with team members and support functions at various levels in the organization.
Ability to grasp new concepts quickly and to assimilate and evaluate scientific data. • Responsible for interaction & collaboration for effective implementation of responsibilities.
Efficient in Computer skills, Management Reporting and Administrative skills, Communication skills.
https://lnkd.in/fhBH7w5