Israel Job Openings
Teva Pharmaceuticals
Associate Director, Regulatory Affairs CMC
Kfar Saba
August 31, 2024
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Associate Director, Regulatory Affairs CMC
Date: Aug 29, 2024
Location:Kfar Saba, Israel, 1
Company: Teva Pharmaceuticals
Job Id: 57043
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 RA CMC Associate Director provides leadership, strategy and guidance to regulatory CMC teams supporting Teva’s production site in Kfar Saba Israel.
The role is responsible for development and implementation of professional standards, streamlined harmonised processes, and to manage the day-to-day activities of the RA CMC teams in line with site priorities and business strategies.
Our global RA CMC team is committed to achieving excellence through harnessing expertise and promoting collaboration, driving compliance and streamlining processes. We foster high-performing teams by embracing Teva’s leadership principles and maintaining an enterprise mindset within the balanced matrix.
How you’ll spend your day
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Planning & Coordination:
- Plan and delegate functional activities, ensuring resources are available.
- Prioritize and coordinate daily tasks of assigned staff and time-critical regulatory activities.
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Regulatory Expertise:
- Collaborate with RA CMC, local site teams and cross-functional teams, on project strategies and compliance throughout the product lifecycle.
- Provide advice and expertise on regulatory issues and strategies for submissions and post-approval changes in various markets.
-
Collaboration & Networking:
- Build networks within and outside the organization to support objectives.
- Promote cross-team collaboration and leverage skills to advance company goals.
- Encourage a collaborative way of working, leveraging available knowledge and skills to support Teva’s overall objectives and success.
-
Compliance:
- Follow ICH guidelines, GMP, and internal SOPs; stay updated on industry regulations.
- Maintain and update SOPs and participate in the Change Control System.
- Ensure proper document archiving and database maintenance.
- Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (all regions), pharmacopoeias and suggest appropriate changes to processes and policies as needed.
-
Resource & Performance Management:
- Manage team headcount and recruitment, set goals, provide feedback, and support staff development.
- Implement company policies, ensure staff training, and maintain clear job description
- KPIs: Monitor and report on functional Key Performance Indicators.
Your experience and qualifications
- University degree in the field of Science, e.g. Chemistry. Advanced degree (M.Sc., Ph.D.) is preferred.
- Minimum of 8-10 years of experience in regulatory affairs or compliance within the pharmaceutical industry, with at least 3-5 years in a leadership role.
- Practical experience in RA CMC
- Practical experience in assessing and writing CTD sections of Registration dossiers
Enjoy a more rewarding choice
Alongside the fulfilling work, the inclusive culture and great rewards, our employees are entitled to a holistic benefits package, which is aimed to provide services required to their, and their families`, physical, emotional and social wellbeing.
In Teva, we understand that alongside your career and professional life, every employee has additional life circles, which include various private and family needs.
This is important to us, and has encouraged us to create one of the most unique and comprehensive benefits package that are offered in the Israeli market. Our benefits package is meant to support you and your family throughout the course of your life and career
In Teva, we understand that alongside your career and professional life, every employee has additional life circles, which include various private and family needs.
This is important to us, and has encouraged us to create one of the most unique and comprehensive benefits package that are offered in the Israeli market. Our benefits package is meant to support you and your family throughout the course of your life and career
Make a difference with Teva Pharmaceuticals
Reports To
Sr Dir Regulatory Affairs
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.
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