Regulatory Affairs Officer

2 weeks ago

Panchkula, India Ind-Swfit Full time

**Roles and Responsibilities**
- 1. Preparation and review of registration dossiers as per CTD/ACTD and country specific formats
2. Review of quality documents like API's DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance
3. Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions
4. Co-ordination with clients for the tracking and status update of project plans
5. Preparation of response to queries raised by regulatory authorities as well as by clients
6. Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders
7. Literature search/survey to compile clinical and non-clinical part within registration dossiers
8. Preparation and review of SPC, Product monograph, package insert and labeling information
US,EUGMP exposure
- **Perks and Benefits**
- Best in industriesRole:

- Regulatory Affairs Compliance- Salary:

- Not Disclosed by Recruiter- Industry:

- Pharmaceutical & Life Sciences- Functional Area:

- Legal & Regulatory- Role Category:

- Corporate Affairs- Employment Type:

- Full Time, Permanent- Key SkillsDossier Compilation

regulatory affairs

product questionnaire

Dmf

Skills highlighted with ‘‘ are preferred keyskills
- Education- PG:

- M.Pharma in Pharmacy

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