Regulatory Affairs Associate (CMC Lifecycle)(Fixed-Term Contract)

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.

Responsibilities

 

• Create, maintain and adapt international registration dossier in line with current trends and legislative changes
• Compile and assess the registration dossier in terms of completeness and compliance with registration requirements
• Actively participate in the change control system and work in line with established processes:
  • Evaluate changes and propose classification and submission strategy in line with applicable regional and local regulations
  • Cooperate with Submission RA functions to align on strategy for submission to authorities in the relevant market
• Prepare the variation packages and other necessary documents as required by the variation process
• Perform regulatory evaluation and assessment of technical documentation intended for inclusion in regulatory submissions, ensuring that the documentation is appropriate for the required purpose and targeted regulatory markets
• Contribute to renewal applications
• Respond to queries (from regulatory authorities, internal departments/affiliates or clients) concerning changes. Manage the process of responding to the
• CMC questions by involving all stakeholders and follow up agreed actions to respond as rapidly and completely as possible
• Work with internal and external partners as required
• Support strategic projects such as technical transfers
• Actively participate in meetings related to registration procedures or when CMC expertise is needed
• Perform punctual and accurate reporting of registration activities in regulatory databases
• Abide by the ICH guidelines and other relevant regulatory provisions
• Represent RA CMC Lifecycle in project teams, as applicable
• Identify and implement process improvements
• Any other duties as required/assigned by the company and/or direct superior

Requirements

 

• MSc degree in Pharmacy, Chemistry or Biology
• 2-5 years of experience in CMC Regulatory Affairs
• Knowledge on registration procedures and pharmaceutical regulation
• Working independently with a moderate level of guidance and direction
• Very good command of English, speaking and writing
• Good IT skills
• Excellent organizational and interpersonal communication skills (both written and verbal)
• Work and collaborate remotely with numerous professionals and stakeholders both within and outside the department towards common goals while coordinating various regulatory tasks
• Analytical thinking
• Accuracy in practice and attention to detail.
• Ability to work under pressure and on own initiative

What We Offer

 

• Competitive salary;
• Benefits packages with a great bonus system;
• Dynamic and professional atmosphere;
• Career development opportunities;

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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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