J&J Pharma & Chemistry Job Opening – Apply Online
JOB TITLE: Executive Regulatory Affairs & Packaging – Mumbai
FUNCTION: Regulatory Affairs Group
SUB FUNCTION: Regulatory Product Submissions and Registration
CATEGORY: Analyst, Regulatory Product Submissions and Registration (P4 – E24)
LOCATION: Mumbai, Maharashtra, India
DATE POSTED: May 08 2024
REQUISITION NUMBER
2406185775W
DESCRIPTION
Executive Packaging & Regulatory Affairs
Designation of Employee: Sr. Executive
Functional Department: Regulatory Affairs
Reporting to: Associate Director /Sr. Manager – Regulatory Affairs
Job Responsibilities: Packaging
- Technology Transfer
- Lead the activities involved in the technology transfer from a packaging perspective:
- To support packaging material characterisation (Engineering Study), Shipping Qualification (Physical), and oversee Packaging validation.
- Prepare and review protocols and reports, development of artworks, and master packing records.
- Packaging material development:
- Prepare specifications for primary, secondary, tertiary, and ancillary packaging materials.
- Preparation of Master Packaging Record (MPR):
- Manage Master Packaging Record review.
- Issue the certified copies of MPR to relevant stakeholders as well as the manufacturing site.
- Manage documentation like master copy, certified copy, and obsolete copies.
- Approvals of printed packaging materials:
- Check proofs and shade cards of packaging materials against approved artworks.
- Manage documentation and distribution of approved proofs and shade cards.
- Document management:
- Keep records of approved artworks and proofs, certified MPR in individual product files.
- Maintain records of imported product artworks in individual product files.
- Keep records of packaging material codes for all printed packaging materials.
Job Responsibilities: Regulatory Affairs
- Preparation, review, and collation of documents for the application for import of new drugs and established products.
- Maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Applicable knowledge of D&C Act, NDPS Act, Legal Metrology Rules, etc.
- Prepare 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.
- Prepare, review, and collate documents pertaining to applications for certifications such as WHO-COPP, GMP, GLP, No Conviction Certificate, Manufacturing & Marketing Certificate, Performance Certificate, Import and Marketing Certificate, and Market Standing Certificate.
- Management of testing samples at private and government laboratories such as CDTL, NIB, IPC.
- Coordinate with EM sites for P2P and Loan License products regarding grant of fresh and renewal of licenses.
- Support 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 FDAs.
- Other responsibilities as assigned, which include reviewing and retrieving data from the public domain.
- Maintain a tracker of all various activities, status of submissions, and approvals.
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 and collaboration for effective implementation of responsibilities.
- Efficient in computer skills, management reporting, administrative skills, and 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.
QUALIFICATIONS
Educational Qualification:
- B. Pharm, M. Pharm, M.Sc. (Chemistry).
- Preferred having: Diploma in Packaging, Diploma in Regulatory Affairs.
Apply for this position here.
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