Mylan Laboratories Limited -Deputy Manager - Regulatory Affairs-k

Job Description 

Primary Location

 IND-Andhra Pradesh-Hyderabad

Organization

 Mylan Laboratories Limited  

Job Number:

 Deputy Manager - Regulatory Affairs  

Description

For Us, It’s A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate.  If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.

 

Make a Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:

• Conducting critical regulatory risk-based assessments of various regulatory applications identified by Business Development as potential development or license opportunities
• Managing the preparation and review of new Abbreviated New Drug Applications (ANDAs) and Food and Drug Administration (FDA) required Annual Reports, amendments and supplemental applications to ANDAs in a multi-tasking environment
• Ensuring operation is under FDA regulations and guidances by providing regulatory advice to other functional areas

 

Qualifications

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the qualifications for this position:

• Minimum of a Bachelor's degree (or equivalent)
• 2-4 years of experience (A combination of experience and/or education will be taken into consideration.)
• Experience with a wide variety of pharmaceutical dosage forms (i.e. solid orals, injectables, etc.) is desirable.
• Expert-level knowledge of the United States Pharmacopoeia, Title 21 of the Code of Federal Regulations and various FDA Guidances for Industry and have the ability to interpret these to apply to Mylan procedures.
• Expert-level knowledge of the regulatory process pertaining to drug development, registration, review, and approval.
• Knowledge of Mylan’s approach with regards to interactions with the FDA. 

Why Mylan?

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 20,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

 

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer.

  

 

Schedule

 Full-time

Job Posting

 Sep 17, 2013, 4:08:08 PM

Unposting Date

 Nov 1, 2013, 10:29:00 AM

 

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