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Regulatory Affairs Specialist II

0 - 1 years

0 Lacs

Navi Mumbai Maharashtra India

Posted:3 days ago| Platform: Linkedin logo

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Skills Required

management flow communication presentation flexibility reports support recruitment

Work Mode

On-site

Job Type

Full Time

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.

The opportunity

  • The Regulatory Affairs Specialist is a project manager, (PM) responsible for the RA lifecycle management on Medis dossiers for Teva’s 3rd party client business (Medis), ensuring information flow and provision of supportive documents reaches the clients
  • The PM is responsible for liaison with Teva’s 3rd party client business (Medis) supply chain, Teva site RA and other relevant functions

How You’ll Spend Your Day

  • Lifecycle management on specific products for Europe and international market
  • Responsible at all times that regulatory modules under Product Manager responsibility are up to date, in accordance with agreed procedure as applicable
  • Inform, prepare and submit variations either directly to authorities or to Teva’s 3rd party client business (Medis)
  • Follow up on variation submissions, timelines and approvals, in accordance with agreed procedure as applicable
  • Compile answers to any deficiency questions from authorities or clients
  • Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable
  • Regular status updates to management
  • Goal setting and follow up together with his/her supervisor
  • Professional communications with both internal and external stakeholders
  • Work on other specialised projects as defined by managers of RA

Your Experience And Qualifications

  • M Pharm/ MSc: 0-1 years of experience in RA
  • Good organisation skills
  • Good communication and presentation skills
  • Good written and verbal knowledge in English
  • Strategic thinking and flexibility to adapt to changes
  • Good team player
  • Good computer skills
  • Proactive way of working and able to work independently

Reports To

Group leader regulatory affairs

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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Teva Pharmaceuticals
Teva Pharmaceuticals

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