Arch Recruiting Solutions Looking for Regulatory Affairs Executive at Lower Parel Full Time

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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