Opportunity for B. Pharma/ M. Pharma as a Executive Regulatory Affairs at Johnson & Johnson Pvt Ltd – Apply Now

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Attention Bachelor’s and Master’s graduates in pharmacy! Johnson & Johnson is currently seeking passionate individuals to join our team as Executive Regulatory Affairs and Packing professionals in Mumbai. Take the next step in your career with a global leader in healthcare. Apply now to become part of Johnson & Johnson’s commitment to innovation and excellence in pharmaceuticals!

Job Responsibilities: Packaging
Technology Transfer

• Lead the activities involved in the technology transfer from packaging perspective:
• To support packaging material characterisation (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.

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Job Responsibilities: Regulatory Affairs

• 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.
• Supporting RA activities for management of product lifecycle management and NPI for cluster countries
• 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.

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Additional Requirements

• 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.
• The above statements are intended to describe the general nature and level of work being performed.
• They are not intended to be construed as an exhaustive list of all responsibilities.

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