Drug Regulatory Affairs Officer-ludhiana(expertise In Cdsco/sugam Portal Regn & Applications)
- P & I Management
- 2 - 5 Years
- Ludhiana
- 2 years ago
- Email to a friend
- Report this job
Job Description
Position- Drug Regulatory Affairs OfficerDesired Candidate Profile
At least 2 years of experience in Domestic Drug Regulatory Affairs.
Education: Science Graduate / B.Pharma / M. Pharma.
Industry Type: Pharma/ Biotech/ Food.
Good knowledge about the Indian Drug Regulatory System.
Knowledge of Dossier Modules, understanding of GMP standards and regulatory guidelines.
Command over written and verbal English communication.
Proficient in computer skills especially MS Office and adobe PDF.
Commitment and ownership.
Proactive and problem-solving approach.
Ability to work with strict timelines.
Job description
Roles and Responsibilities
Strategic planning for formulation development of DCGI batches in Plant to ensure timely submission in CDSCO
Planning, compilation, review and submission of dossiers related to Import and Registration, New Drug permission, test license etc. to CDSCO.
Uploading the documents on SUGAM portal and on the portals of other State Regulatory Authorities.
Handling and responding to all the product specific queries.
Ensuring overall compliance to domestic regulatory requirements.
Co-ordination with respective departments.
Maintaining familiarity with company product ranges.
Keeping up to date with changes in regulatory legislation and guidelines.
Ensuring that quality standards are met and submissions meet strict deadlines.
Maintain high levels of accuracy, meet tight deadlines.
Management of Data.
Handling work related to planning and timely procurement of Innovator sample.
Handling work related to CROs i.e. planning, selection, completion of BE, CT, Toxicity studies.
Preparing DRA's MIS presentation (Quarterly basis) to management.
Preparation and submission of DRA's Performance review plan (PRP) (Quarterly basis) to Management.
Maintaining Product Registration Certificates received.
Timely answering Queries raised by Health Authorities of respective countries and customers.
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life Sciences
Functional Area: Quality Control
Role Category: Pharmacist
Role/Responsibilies: Drug Regulatory Affairs Officer-ludhiana(expertise In Cdsco/sugam Portal Regn & Applications)
Contact Details:
Company: P & I ManagementLocation(s): Ludhiana
+ View Contact
Fraud Alert to job seekers!
₹ Not Specified
P & I Management
Established in 1994, P & I offers on demand Recruitment Services accross all fields, functions and industries to Job seekers & employers located in Punjab, Himachal, Haryana & all over India. Clients may contact us by mail or in case of urgent need, call Sudesh Bali on 09316914978/01612564474/836005...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in
