Regulatory Affairs Associate - 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 lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.

How you’ll spend your day

• Support the life cycle management of APIs from RA perspective 
• Review and approve ROS, specification and analytical control when required
• Coordinate DMF preparation and related activities for On Time Submissions for all relevant markets
• Proactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requests
• Prepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments. Follow up on the gaps' solving during the review period 
• Respond to deficiency letters and coordinate related activities
• Coordinating pre-launch activities from RA perspective
• Manages the regulatory aspects and related tasks of the assigned commercial APIs 
• Evaluate change requests and address the required submission per market to support the requested change. Follow through the submission
• Maintain up to date the DMFs according to the required regulation of updating per market.
• Support customers regarding Service Requests, giving relevant professional information in the shortest of time
• Continue learning of regulatory guidance, SOPs and work processes

Your experience and qualifications

• Excellent Communication: Strong verbal and written skills, both internally and externally.
• Customer-Centric Approach: Dedicated to providing high-quality service to both internal and external stakeholders.
• Leadership and Teamwork: Effective leadership skills and ability to collaborate effectively with others.
• Organization and Planning: Strong organizational skills and ability to meet deadlines.
• Adaptability and Learning: Open to new ideas, self-motivated, and capable of continuous learning.
• Initiative and Proactivity: Takes initiative and is proactive in seeking solutions and opportunities.
• Attention to Detail: Meticulous and accurate in work execution.
• Time Management: Effective time management skills and ability to prioritize tasks.
• English Proficiency: Fluent in English, both written and spoken, at a professional level
• Education 
• High degree in a relevant field, e.g. chemistry/biochemistry/biology or biotechnology

Reports To

Mgr Regulatory Affairs, RA|IL(TAPI RA)

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.