Require Executive Regulatory Affairs & Packaging at Johnson & Johnson

Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.

Post : Executive Regulatory Affairs & Packaging

Job Description
Regulatory
• 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) :
• Technology Transfer: Lead the activities involved in the technology transfer from packaging perspective. To support packaging material characterization (Engineering Study), Shipping Qualification (Physical), Oversee Packaging validation. Prepare and review Protocols & reports, Development of Artworks, Master Packing Records
• Packaging material development: Prepare specifications for primary, secondary, tertiary & ancillary packaging materials.
• Preparation of Master Packaging Record (MPR): Manage Master Packaging Record review. Issue the certified copies of MPR to relevant stake holders as well as manufacturing site Documentation like Master copy, Certified copy and Obsolete copies.
• Approvals of printed packaging materials: Checking proofs/shade cards of packaging materials against approved artworks. Management of documentation and distribution of approved proofs/shade cards.
• Document management: Keep the record of Approved Artworks & Proofs, Certified MPR in individual product files. Keep the records of imported product artworks in individual product files. Keep the records of packaging material codes for all printed packaging materials.

Candidate Profile
• B. Pharm, M. Pharm, M.Sc. (Chemistry)
• Preferred having: Diploma in Packaging, Diploma in Regulatory Affairs
• 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.

Additional Information
Qualification : B. Pharm, M. Pharm, M.Sc
Location : Greater Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
Requisition ID : 2005809447W
End Date : 10th April, 2020