Job Description

Department : Regulatory Affairs

Post: Officer or Executive

JOB DESCRIPTION:

1) Dossier Preparation & checking in ACTD/CTD/Country Specific format for ROW Market (Asia, Africa, Latam, CIS Market) & to ensure error free & timely submissions as per marketing Dept. timeline.

2) To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.

3) To review & prepare technical documents like Specifications, BMR, process validation, Analytical Method Validation (AMV), Manufacturing Process Validation (PV), Pharmaceutical Development (PD), Stability, composition, Comparative Dissolution Profile (CDP) and BA/BE Studies, Drug Master File (DMF) etc. received from facotory QA or R&D/ADL for its regulatory adequacy before implementation in the dossiers

4) To Co-ordinate respective dept. in HO /Plant /ADL/R&D for documents & samples, RS, WS required for dossier / registration purpose.

5) Co-ordination with API /PM vendors to resolve technical queries w.r.t. regulatory requirements.

6) Artwork development (Carton, Label, PIL) of products & Checking according to country specific requirement with co-ordination of Artwork designing department for registration and commercial purpose as per regulatory requirement.

7) To Maintain & Update all documentation & dossier record; to update registration status.

8) Dispatching sample for registration /Re-registration & maintain their records.

9) Co-ordination with Licensing Department for legal documents like Mfg Lic / FSC /COPP etc.

10) Site Registration in different countries.

11) Trademark application, updating status & maintain records.

12) Should be well versed with the preparation & online submission for FDA application e.g. PP, COPP, loan license, WHO-GMP, applications and renewals.

QUALITIES:

1) Good Technical knowledge of QA, QC and Production.

2) Good Technical knowledge of AMV, PV, BA/BE Studies, CDP, PD and Biowaiver studies.

3) Good understanding of ICH and regional regulatory guidelines should be able to interpret guidelines and apply them in practical situations independently.

4) Should have an eye for detailing, good communication skills, self-motivated, ready to learn & grasp.
5) Should be aggressive in liaising with plant in order to get documents & must be able to achieve targets set.

QUALIFICATION:
B. Pharm/ M.Pharm. (Full Time) from recognized University

Work Experience:
3 to 5 Yrs. of relevant experience.

Salary:
Not disclosed

Share your CV at
ameghhr@gmail.com