Regulatory Affairs Specialist II - Maternity leave replacement

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

To support RA associates in all administrative activities related to registration, electronic submission, maintenance of Drug Master Files (DMF) and answering customers' requests.

How You’ll Spend Your Day

• Prepare and maintain electronic submissions (eCTD) of DMFs, via a publishing system, according to industry guidelines.
• Submission of DMFs, prepared by RA team, to authorities according to relevant guidelines.
• Routine support and collaboration with the Regulatory Affairs Associates team members in administrative activities related to submissions and technical preparation of DMFs.
• Answering and supporting customers' requests by providing administrative information (DMFs, CEPs, Deficiency letters responses prepared by RA team) and additional categories as needed, via CRM.
• Filling RA documents in CRM and Smarteam systems.
• Distribution of costumer notifications prepared by RA team via the CRM system.
• Learning of submission regulatory guidance and internal work processes
• Working with several submission systems in parallel and different gateways according to authority's requirements.
  
  

Capabilities

Your experience and qualifications

• Good human communications
• High service approach to internal & external customers
• The ability to adapt to new ways of working and learn new processes.
• Organized
• Technical skills
• Individual work ability as well as teamwork
• Meeting work target timelines
• Readiness to work when required
• Ability for self-learning
• Initiative
• Self-motivated
• Time management
• English - good professional level, both in writing and speaking
• Former experience working in a pharma company/regulation (advantage)
  
  

Education;

• University degree in science (B.Sc.)
  
  

Reports To

Regulatory Affairs Manager

Already Working @TEVA?

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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.