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

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Cég neve

Teva
Munkavégzés helye

Debrecen

Munkaidő, foglalkoztatás jellege
- Teljes munkaidő
- Alkalmazotti jogviszony
Elvárások
- Angol felsőfok
- 1-3 év tapasztalat
- Főiskola

Teljes munkaidő Alkalmazotti jogviszony

Angol felsőfok 1-3 év tapasztalat Főiskola

Állás elmentve

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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;

Company info

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.

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