Job Description
Candidate will based at Mumbai.
You will be responsible for,
• Candidate will be responsible for Preparation & review of product registration/renewal of dossiers (CTC/ACTD) for Canada market.
• Candidate will be responsible for heading the RA Dept. activities with respect to dossier of sterile and Non- Sterile product.
Preparation for registration/renewal of registration, manufacturing license with products, WHO-
GMP Certificate, MSO registration, etc.
• Candidate will be responsible for to obtain additional product permissions, test license,
Certificates.
• Candidate will be responsible for to submit the required information to regulatory authorities.
• Candidate will be responsible for obtain product permissions, test license, plan approval, etc
• Candidate will be responsible of ANDS submission
Required Candidate Profile
• Candidate should be B. Pharma / M. Pharm / with minimum to 5 to 8 years experience in reputed
Pharma Formulation and candidates should have experience in Handling Regulatory Affairs for
Canada market.
• Preparation & review of product registration/renewal of dossiers (CTC/ACTD) for Regulated markets
• To ensure regulatory compliance as per Market authorizations.
• To check the artworks for compliance with regulatory and pharmacopoeia requirements of products.
• To ensure regulatory compliance as per D&C Act and Marketing authorizations.
• Candidate should have experience in Sterile and Non- Sterile Product exposure.
,
This job is provided by Shine.com
You will be responsible for,
• Candidate will be responsible for Preparation & review of product registration/renewal of dossiers (CTC/ACTD) for Canada market.
• Candidate will be responsible for heading the RA Dept. activities with respect to dossier of sterile and Non- Sterile product.
Preparation for registration/renewal of registration, manufacturing license with products, WHO-
GMP Certificate, MSO registration, etc.
• Candidate will be responsible for to obtain additional product permissions, test license,
Certificates.
• Candidate will be responsible for to submit the required information to regulatory authorities.
• Candidate will be responsible for obtain product permissions, test license, plan approval, etc
• Candidate will be responsible of ANDS submission
Required Candidate Profile
• Candidate should be B. Pharma / M. Pharm / with minimum to 5 to 8 years experience in reputed
Pharma Formulation and candidates should have experience in Handling Regulatory Affairs for
Canada market.
• Preparation & review of product registration/renewal of dossiers (CTC/ACTD) for Regulated markets
• To ensure regulatory compliance as per Market authorizations.
• To check the artworks for compliance with regulatory and pharmacopoeia requirements of products.
• To ensure regulatory compliance as per D&C Act and Marketing authorizations.
• Candidate should have experience in Sterile and Non- Sterile Product exposure.
,
This job is provided by Shine.com
💡 Quick Summary
Seeking a career-building opportunity? The Executive | Sr| Executive Regulatory Affairs| Pharma position is now open for candidates interested in the MIS Executive sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in MIS Executive is a plus.
