Cipla jobs - Team Member - Regional RA

Team Member - Regional RA

Cipla
experience 3 to 4 Years
salary Salary not disclosed
qualification
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Posted: 2 Months ago
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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

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Job Particulars

Job TypeApprenticeship
Hiring Process Face to Face Interview

About Company

Cipla
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Cipla recruiting Team Member - Regional RA Experienced(3 to 4 Years) candidates candidates nearby Mumbai,.Cipla vacancies for Team Member - Regional RA is recruited through Written-test, Face to Face Interview etc.
Cipla Company recruits a lot of Experienced(3 to 4 Years) candidates candidates every year based on the skills . The candidates with B.Pharm, M.Pham, MSc, Other Course are selected to full fill the vacancies in Pharmacist / Medical Rep job field. The candidates nearby Mumbai, can apply for Team Member - Regional RA position in Cipla. All candidates should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to the Cipla recruitment, candidates are mostly chosen for the department of Pharmacist / Medical Rep . To learn more about the current jobs and other details, it is better to go through official site of Cipla and Teamlease.com. Find the latest jobs near you and near your home. So, that you don’t need to relocate. The Teamlease.com is a leading employment portal that researches the official site of Cipla and provides all the details about the current vacancies, the application process, selection process, interview test details, important dates and other information. Search and apply for the top job positions in Cipla and near your city and get a secured career.