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Manager Regulatory Affairs For A Fast Growing Pharma Co., Mumbai Jobs

Aspiring Solutions
Job Description
We are urgently hiring for Manager Regulatory Affairs for a fast growing Pharma co. for their HQ located at Chandivali, Mumbai . Please find the details below:
Company Name: Fast Growing Pharma Co.
Requirement: 1 Nos.
Job Location: Chandivali, Mumbai
Designation: Manager Regulatory Affairs
Education: B.Pharm/ M.Pharm
Experience: 10-15 years experience into Pharma Regulatory
Industry: Pharma/ Biotech
Function Area: Regulatory Affairs
Key Skills: ROW, CTD, ACTD, pharma regulatory affairs, RA, manager, formulation
Salary Range: 10-12 Lacs per annum
Job Profile:
Experience in compilation, review and submission of CTD dossiers to foreign drug agencies in ROW markets as well as general laisoning with the local FDA.
Interacting with the R&D centre as well as respective manufacturing sites.
Overall responsibility for timely submission of dossiers to the companys foreign branches as well as replies to the concerned foreign agencies.
Responsible for the company to maintain its local GMP and product licenses from the Maharashtra FDA and the CDSCO.
Write high quality deficiency response to various regulatory authorities.
Knowledge of commercial regulatory requirements for all the regulated markets.
Should have knowledge of registration process , plant audits.
Compilation & review of dossier including technical data package.
Review of Batch records, specification, art work, and packaging material, analytical method validation documents, development documents, PDR and labelling.
Must also have knowledge of about ROW market and other market from dossier preparation and query solving point of view.
Qualities Needed for This Jobs
Regulatory Affairs Manager, ROW, Pharma, Mumbai, RA, QA, Quality Assurance, Dossier Filing
Candidate Profile
B.Pharm and/or M.Pharm graduate.
Have 10-15 experience in regulatory and/or quality assurance.
well versed with the FDA & CDSCO online portal
well versed with the drugs & cosmetics act, in particular Schedule M & WHO guidelines.
Male Candidates preferred
Looking for MBA / PGDM / MBM , B.Pharma , Diploma , M.Pharma graduates profile.
Company Profile
About Aspiring solutions
Greetings from Aspiring-Solutions!!

We would like to take this opportunity to introduce ourselves as a recruiting consultant providing manpower hiring services as per the clients requirements.

Aspiring-Solutions is a passion driven and one stop over HR consulting services based in Mumbai. We undertake bulk operations and specialize in undertaking all level recruitments inorder to cater the needs of different companies. Our motto is to provide quality candidates so as to meet the set expectations of our clients.

We aim in having long lasting customer relationship based on the strong foundations of meaningful consulting, quality services and dedicated support system.

We prove to be beneficial to both the employer and employee.

We value your relationship with us!!
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More Information
Location Mumbai
Education MBA / PGDM / MBM , B.Pharma , Diploma , M.Pharma
Experience 0 (yrs)
Industry Pharma
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