J&J Regulatory Executive Job Vacancy – Pharma & Chemistry
Pharma Pharmaceutical Science & Chemistry Job. Johnson & Johnson is a leading company with numerous job openings for chemistry candidates. J&J is currently hiring for a Scientist job. Pharma job opening 2019. Check out all the details on Rasayanika.com
Job Title: Executive Regulatory Affairs & Packaging
Location: Greater Mumbai, India
Req Id: 2005809447
Function: Regulatory Affairs
Qualifications
Education:
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.
Key Responsibilities:
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.
Editor’s Note: J&J Regulatory Executive Job Subscribe to Rasayanika for latest chemistry and Pharma job openings, follow us on Facebook and Whatsapp and subscribe to our youtube channel for latest updates on chemistry and Pharma jobs and much more.
