• Mgr Regulatory Affairs Jobs in Mumbai,India - 25367225

  • Teva Pharmaceutical Industries ltd
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

Company Info

Teva is a global pharmaceutical leader and the worlds 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 worlds largest medicine cabinet to 200 million people every day We offer a uniquely diverse portfolio of products and solutions for patients and weve 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!



RA professional with in depth technical knowledge of CMC aspects, dossier compilation, review, evaluation and compilation of post approval changes

Hands on experience to review and approve submission documents in accordance with the regulatory guidelines, evaluate changes in CMC documentation with respect to its impact on regulatory submissions, strategize filing categories, compile submissions to Europe, International market

Coordinate with internal and external stakeholders and compile high quality regulatory submissions,within stipulated timelines and accordance to the guidelines, ensuring submission documents are accurate, compliant, and high-quality

To assess regulatory documents in consideration and compliance with the regulatory requirements at a preliminary level & provide inputs to cross functional team to support business requirements

Independently evaluate change controls with respect to its impact on regulatory submissions, strategize filing category, compile submissions and resolve complex issues as they raise for EU, international markets

Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment

Result-oriented with concerns for quality and the ability to handle multiple tasks and work in a cross-functional team environment and project teams/ buisness units

Qualifications

MPharm/BPharm with 10- 13yrs of experience in Regulatory Affairs

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Senior Manager - Regulatory Affairs

Tevas Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment It is Tevas 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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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