Job details
Salary
₹3,00,000 – ₹7,00,000 a year
Job Type
Full-time
Qualifications
– Bachelor’s (Required)
– Regulatory affairs: 2 years (Required)
– CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries: 2 years (Required)
– ROW, LATAM,ASEAN,MENA: 2 years (Required)
Benefits
Pulled from the full job description
Flexible schedule
Full Job Description
Urgent Requirement
Location – Lower Parel, Mumbai
Designation – Regulatory Affairs- Executive
Experience – 2yrs – 6yrs
Qualification – B Pharma
Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals.
Other essential skills: Regulated markets
Job description:
Common requirements:
1) Complete understanding of requirements & regulations of regulated markets wrt New submissions, Re-registration & Variations.
2) Prior experience in carrying out high-quality CMC reviews of all kinds of technical documentation & Art-works,
3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal.
3) Variations submission
4) Must be an Individual contributor + Good team player.
Specific requirements:
1) Collate, compile & author high-quality CTD sections for M1, M2, M3, M4 & M5.
2) Detailed review of technical documents required for Regulatory submissions e.g. PVP/PVR/AMV/Stability report & Protocol/Specifications/ COAs/ BE study/ DMF etc.
3) Coordinate with Client/ Plant for required documents/ samples/ working standards etc. through emails/ phone calls for smooth running of Projects.
4) Utmost care is recommended to minimize the unwanted errors while working with documents i.e. authoring & reviewing the data.
Interested applicants can share their CVs at the earliest.
Job Type: Full-time
Salary: ₹300,000.00 – ₹700,000.00 per year
Benefits:
– Flexible schedule
Schedule:
– Day shift
Ability to commute/relocate:
– Lower Parel, Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Education:
– Bachelor’s (Required)
Experience:
– regulatory affairs: 2 years (Required)
– CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries: 2 years (Required)
– ROW, LATAM,ASEAN,MENA: 2 years (Required)
Speak with the employer
+91 9960966889
Hiring Insights
Application response rate: 94%
Hiring 1 candidate for this role
Job activity
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