Regulatory Affairs Associate @ B Pharm / M
Pharm
Date: Oct 3, 2019
Location: Navi Mumbai, IN, 400706
Company: Teva Pharmaceuticals
Company Info
Teva is a global pharmaceutical leader and the
world's largest generic medicines producer, committed to improving health and
increasing access to quality health solutions worldwide. Our employees are at
the core of our success, with colleagues in over 80 countries delivering the
world's largest medicine cabinet to 200 million people every day. We offer a
uniquely diverse portfolio of products and solutions for patients and we've
built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric
solutions and significantly growing both our generic and specialty medicines
business through investment in research and development, marketing, business
development and innovation. This is how we improve health and enable people to
live better, healthier lives. Join us on our journey of growth!
Job Description
Role Description Summary:
Providing regulatory for New Product
submission (Pre Approval Activities).
Description of KEY responsibilities (describe
the main results of the job to be achieved):
Ensure the requirements for submission of
ANDAs & EU MA applications.
Review and compile documents for New submissions & DLs responses and
ensure the high quality content/document for product submissions in line with
USFDA/ HC requirements
Skills and specific knowledge required
Knowledge and experience on preparation of
dossiers and electronic submission for Health Authorities for North America
markets
Aware of various health authority guidelines
like ICH, USFDA, EU
Hand’s on productivity Applications tools like
eCTD, Adobe Acrobat etc.
Job Description
Review of analytical methods validation
protocols and reports of Drug substance and Drug product meeting ICH
requirements.
Timely review of documents (e.g. Master
Manufacturing Formula, PDR, Specifications, Stability guidance documents,
Comparative dissolution profiles) for Regulatory Dossier submissions.
Compilation of Dossiers for ANDA/ ANDS
submissions.
Drafting of responses for Deficiency letters
or Clarifaxes
Review of Compiled dossiers
To maintain and update regulatory database
Qualifications
Job Qualification
B Pharm / M Pharm
About 5 years’ experience in the profession of
Regulatory Affairs
Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To
In process of validation
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal
opportunity in employment. It is Teva's global policy that equal employment
opportunity be provided without regard to age, race, creed, color, religion,
sex, disability, pregnancy, medical condition, sexual orientation, gender
identity or expression, ancestry, veteran status, national or ethnic origin or
any other legally recognized status entitled to protection under applicable
laws.
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