Regulatory Affairs Associate II
Location
Nagar | India
Job description
Who We Are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
How You'll Spend Your Day - Preparation of DMF, ASMFs, CEP application and their registration processes in the regulatory regions [US, Canada, Europe, Japan etc] as well as ROW.
- Preparation of Applicants Parts, Tech Pack, life cycle management [updates, amendments, CEP revision & variations].
- Drafting of response to Agency's deficiencies and customer DMF review comments for all global regions.
- Sound knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
- Preparation and submission of form 41 application for import registration certificate to CDSCO.
- Good scientific conceptual knowledge to review and evaluate the R&D, AR&D, QA, QC documents (Change controls, stability report, analytical validation report etc) at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
- Acquainted with eCTD software. Should have hands on experience on eCTD regulatory submission tools.
Your Experience And Qualifications MSC/B. Pharm / M. Pharm.
3.5 to 6 years
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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
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