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Regulatory Affairs Specialist/Senior Specialist

Pfizer


Location:
Warsaw, IN
Date:
12/01/2017
2017-12-012018-01-01
Pfizer
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Job Details

Pfizer, a global leader in the biopharmaceutical industry is continuously seeking fresh new talent to join our brilliant community and share our vision for the development of innovative therapies that make the world a healthier place. A role at Pfizer is unlike any other. Offering talented individuals the opportunity to own a career with real impact, our people go to work each day in the knowledge that every development signifies real, positive progress. We all believe in our ability to improve the future of healthcare, and in our potential to transform millions of lives. Because in every part of the world, the work we do is reaching everyone, everywhere for almost every medical need. With this breadth of ambition comes vast opportunity, providing an environment where determined, resilient professionals can learn and grow. It creates a dynamic ownership culture of diverse personalities, where everybody has equal chance to make an important contribution to our success. Currently, to our office in Warsaw, we are seeking qualified candidates to fill the position of:



**Regulatory Affairs Specialist/Senior Specialist**







**This is what you can look forward to:**







+ In this position you will be responsible for managing the new registrations, license maintenance and related activities for the assigned products



+ You will be accountable for the regulatory compliance within the area of responsibilities



+ You will process Marketing Authorization (MA) applications, renewals, variations etc. for products of all registration procedures, according to global/regional plans.



+ Handling with all relevant global databases and systems and keep updated the local registration tracking of all applications



+ Play an active role in product quality issues actions in order to minimise the impact on business.



+ You will manage stakeholders relations by providing accurate, consistent, timely and balanced responses to the Regulatory inquiries as well as by attending meetings across Pfizer providing guidance to support the development of regulatory activities and strategies



+ Aditionally, you will provide support for all audits and inspections as needed







**What you offer:**







+ You have a life science, medical science, pharmaceutical or chemistry education



+ You have more than 2 years of experience in Regulatory Affairs



+ Maturity and very good understanding of National, EU and ICH directives and regulations



+ Ability to work independently with limited supervision



+ Proven ability to consistently deliver to time, cost and quality standards



+ Ability to interpret and relay technical information



+ Keen analytical skills and attention to detail



+ Excellent team working and interpersonal skills



+ Furthermore you have fluent language skills in Polish and English







**What we offer:**







+ Employment contract and necessary tools



+ Annual bonus eligibility



+ Medical care, life-insurance, Multisport etc.



+ International environment and great development opportunities **Please apply in English only!**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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