regulatory affairs executive

1) Responsible for obtaining approval for new pharmaceutical product

2) Updating legal or regulatory knowledge

2)Learn the regulations that apply to the products in said subfield

3)Compilation of Dossier as per Country requirement i.e. CTD,ACTD or Country Specific .

4)Co-ordination with  F & D, BD, QA,QC, Purchase as per relevant Department for Document requirement

5)Handling of Query as per Ministry of Country

6) Reviewing documents required for submissions to ensure they are appropriate for submissions.

7)  Maintained RA product files to support compliance with regulatory requirements.

8)  Provided regulatory support for currently marketed products as necessary.

9)  Maintains status registration of each country per distributor or representative agent of each product line.

10)  Variation filing for product as per country guideline

11) Reviewing & checking of Artwork as per country requirement.

12)Responsible for the interpretation, direction, determination, and reporting of regulatory agency requirements.

13)  FDA Application : Product Permission, Free Sale Certificate, Certificate of Pharmaceutical Product, Test  License, Renewal Manufacturing License for Own & Loan.

Minimum Skill Required

1. Excellent Communication Skills (Written as well as spoken) are a must
2. Knowledge of Pharmaceutical Products.
3. Ability to prepare and assist in preparation of various regulatory documents.
4. Ability to perform against stiff targets & target work should be finished within time
5. Well versed in MS OFFICE (Excel, Word, PowerPoint)
6. Ability to handle multiple projects deliverables at the same time.

About company (Industry, Size, Products/Services, Standing in India/World etc.)

Pharmaceutical Manufacturer and exporter of formulations (tablets/capsules), Supplements, and semi finished dosages (DC Granules).Been in business for 30 years with reputation for high quality and wide range of medicines across therapeutic categories.

Desired profile of the candidate

Candidate preferred be from Pharma / CDMO / EOU pharma companies
Background.

Learning Attitude.

Experience

1 – 10 years

Salary (Min & Max)

 As per Candidate & Exp

Qualification

B.Pharm/M.Pharm

Job Location

Hyderabad, India

experience