Cipla jobs - Team Member - Regional RA

Team Member - Regional RA

Cipla
experience 3 to 4 Years
salary Salary not disclosed
qualification
Read More...
share this job
save job
Job is expired
Posted: 3 Years ago
Views: 2
Applications: 7
Openings: 1

Job Description

Division
IPD

Department
Regulatory Affairs

Employment Type
Permanent

Job Purpose
Submit product documents to regulatory authorities (specifically in SAGA (South Africa / Greater Africa)) region in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle

Accountabilities
Compilation and finalization of RA strategy documents for South Africa, Namibia and Botswana.

Coordination with India based CDT team and 3rd parties to receive the dossier sections for SA, Namibia and Botswana submission Compile the dossier sections for 3rd party products (as applicable).

Follow-ups and arrangement of FP samples, relevant FPCoA, Executed BMR, BPR and other data from Manufacturing site, to get declaration letters and GMP cerficates without impactng dossier submission timeline.

Coordination with different stakeholders like API – RA (if the API supplier is In-House) and Procurement team to get confirmation on DMF.

Coordination with different regional Regulatory colleagues to get registration cerficates, PI & PIL and also to cross verify about Mfg. formula of their respective countries

Coordination with clinical team to review and complete BTIF as per guideline and alignment with Module 5.

Review of deficiency letter and then arrange for CFT with the right stakeholders for discussion.

Actively participate in each discussion with the cross funconal team and provide feedback upfront for gap analysis compilation by Mfg. site personnel.

Timely review of Unit gap analysis & provide feedback on any amendments needed; for products idenfied for South Africa launch from time to time

Participation and detailed discussion for gap analysis closure meeting

Keeping up to date with registraon guideline (new guideline & amendment guideline) and company practice and SOP’s

Timely review and provide feedback on market complaints & NCE from different authorities on API Suppliers and excipient suppliers

Review and Clearance of artwork, CMCL, SPS from respective software

Time to time updation in PRC database, RA table updation,

Education Qualification
B.Pharmacy, M. Pharm, or MSc

Relevant Work Experience
Minimum 3-4 years experience in regulatory activity in pharma industry preferably worked for same region/authority (South Africa / Greater Africa - SAGA)

Job Location
Vikhrol, Mumbai

Job Particulars

Who can applyExperienced (3 to 4 Years)
Hiring Process Face to Face Interview
Employment TypeApprenticeship
Job Id514361
Job Category Pharma
StateMaharashtra
Country India

About Company

Cipla
Jobs By LocationVIEW ALL
Active Jobs By Role
Accountant (3638) Admin (20) Agriculture and Dairy (0) Architect (572) Bartender (0) Beauticians / Spa (16) Bouncer (0) BPO / Customer care (26433) Caretaker / Nanny (0) Carpenter (1) Cashier (1) Cleaner / Washer (0) Construction / Laborer (1) Content Writer (581) Cook / Chef (73) Counsellor (242) Data Entry / Back Office (16094) Data Analytics (2) Design / Animation (2995) Delivery (88) Digital marketing / SEO (898) Draughtsman/Draftsman (0) Doctor / Physician (76) Driver (7) Electrician (5) Engineer (39369) Engraver (0) Event Planner (0) Fire Fighter (1) Fitter (2) Gardener(Mali) (0) Ground Staff (3) Hospitality Executives (297) Housekeeping (8) HR (1703) Insurance Consultant (0) IT Hardware Engineer (1958) IT - Mobile Developer (2903) IT Software-Engineer (22963) IT Software-QA/Tester (19) Lab Technician (1) Language Translator (1) Legal (2) Librarian (0) Management Trainee (1279) Mechanic (470) Media / Journalism (294) MIS Executive (7) Moulder (0) Nurse (570) Nutritionist / Dietician (0) Office Assistant / Helper (9) Operations (9) Operator / Machinist (3) Packager (2) Painter (0) Pharmacist / Medical Rep (849) Photographer / Videographer (1) Physiotherapist (1) Research/JRF/SRF (67) Plumber (0) Receptionist / Front Office (1094) Retail / Store Executive (204) Rigger (0) Sales / Marketing (6810) Security / Guards (5) Sports Trainer (0) Tailor/ dress designer (90) Teacher (335) Tool & Die Maker (2) Tourist Guide (0) Trainer (10) Waiter / Steward (2) Ward Boy (0) Warehouse Executive (4) Welder (1) Others (732)
safety tipsSafety Tips
Teamlease does not charge any kind of payment for a job.
get job tipsHow to get a Job early? Follow these tips

1.The more the Jobs you apply, the higher your chances of getting a job.

2. Keep your profile updated Update

Recruiters prefer candidates with complete profile information.

3. Keep visiting the Teamlease.com daily

Daily visit will ensure you won’t miss out on any Job opportunity.

4. Watch videos to improve Watch videos

Be a better candidate than others by watching these Job-related videos.