Job Description

Designation

-

- Regulatory Affairs Officer

Industry:

-Inducare Pharmaceuticals & Research Foundation

Qualification:

- B. Pharm / M. Pharm / M. Sc (Chemistry / Pharma)

Experience :- 5-6 years

experience in

QC / QA / Regulatory support

Experience in

tablet and capsule manufacturing

preferred

Job Location : - Jejuri

Skill :

Strong knowledge of

QC documentation and GMP

Understanding of

Regulatory Affairs and compliance requirements

Familiarity with

stability studies, validations, and CTD/ACTD concepts

Good

written and verbal communication in English

FDA audit exposure preferred

Key Responsibilities:

Prepare, review, and maintain

Regulatory documentation

for tablet and capsule formulations Compile

QC data

(Raw Material, In-process, Finished Product, Stability) for regulatory submissions Support

product registration, renewal, and variations

with regulatory authorities Review and evaluate

stability studies

and shelf-life justification Review

method validation, process validation, cleaning validation

protocols and reports Ensure

labeling, artwork, pack insert

compliance as per Schedule H/H1 and Legal Metrology Prepare and review

SOPs, STPs, specifications

as per regulatory requirements Handle

Regulatory and Customer Questionnaires

, declarations, and checklists Respond to

technical queries

from regulatory authorities and customers Provide

audit and inspection support

(State FDA, Central FDA, Customer audits) Assess regulatory impact of

Change Controls, Deviations, OOS/OOT, CAPA

Coordinate with

QC, QA, Production, R&D

departments for compliance activities Stay updated with

current regulatory guidelines

(Schedule M, GMP, ICH)

Job Location: Jejuri Pune Salary : As per experience & competetacy.

Experience:

5-6 years

experience in

QC / QA / Regulatory support

Experience in

tablet and capsule manufacturing

preferred
Job Type: Full-time

Pay: ?360,000.00 - ?500,000.00 per year

Benefits:

Paid time off
Ability to commute/relocate:

Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Education:

Master's (Preferred)
Experience:

total work: 1 year (Preferred) Production officer: 1 year (Preferred) Pharmaceutical: 1 year (Required)
License/Certification:

FDA Approved (Preferred)
Work Location: In person