Mylan Looking forRegulatory Affairs Manager

Mylan Laboratories Limited  Looking For

Regulatory Affairs Manager

Role : Regulatory Affairs Manager

Qualification :

M.Pharma in Pharmacy
B.Pharma in Pharmacy

Experience : 3 - 8 Years

Vacancies : 6

Location : Bengaluru (Jigani), Hyderabad (Gachibowli)

Job Description :

• Mylan is hiring for our Regulatory Injectable R&D vertical at Bangalore

• The role holder is responsible for execution of all activities related to review of executed documents, compilation of the dossier, deficiency.

• Co-ordination with cross functional teams for completion of the assigned activity. 

• This role reports to supervisor and is an individual contributor.

• Execute regulatory team activities as directed to achieve submission approval.

• Maintain general knowledge of regulations and guidance for one or more product types (Injectables, API, etc.) within designated region(s).

• Coordinate with stake holders (RnD, Plant and suppliers) for sourcing of documents and review of executed documents received.

• Review and evaluation of change control documents related to CMC. 

• Approval of change control documents and quality information's as assigned

• Preliminary review of the dossier submission.

Recruiter Details

C Prakash

Senior Manager at Mylan Laboratories

Limited

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About Company

Mylan Laboratories Limited is a global healthcare company focused on making high quality medicines available to everyone who needs them. Mylan heritage of being a provider of generic pharmaceuticals goes back to our founding in West Virginia in 1961.

Today, Mylan Laboratories Limited is passionate champions for better health around the world with a platform unmatched inthe industry.

Mylan Laboratories Limited have one of the broadest and most diverse portfolios, with more than 7,500 marketed products that include prescription generic and brand-name medicines, and consumer healthcare products.

Mylan Laboratories Limited healthcare services help patients to access products and adhere to medication regimens to help promote better health outcomes.

Mylan Laboratories Limited now offer products in more than 165 countries and territories. And depending on the market, Mylan  products are distributed through retail channels, by healthcare professionals or in institutional settings.

Mylan Laboratories Limited have a strong track record of developing new products, particularly complex and difficult to formulate medicines.

Mylan Laboratories Limited approximately 50 plants around the world manufacture tens of billions of doses of medicine annually, and each site adheres to stringent quality standards, regardless of location.

Mylan Laboratories Limited most valuable asset is our global workforce, each member of which is a passionate supporter of our cause to deliver better health for a better world.