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Regulatory Affairs Manager


Mission Viejo, CA 92691
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Job Details

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talents who share our core values and mission of making the world a healthier place. For our Pfizer office in **Budapest, Hungary** we are looking for a **Regulatory Affairs Manager.**

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

Management of the new registrations, license maintenance and related activities for the assigned products under the supervision of the Head of the Sub-Cluster. Be accountable for the regulatory compliance within the area of responsibilities. Provision of regulatory advice to and liaison with key customers. Your responsibilities will include:

+ Preparation of Marketing Authorization applications, renewals, variations and related activities

+ Collate, coordinate and, where required, create the necessary technical data to support the submission of new Marketing Authorization applications, renewals and variations

+ Support the European wide application process for the assigned products, clarifying the requirements and ensuring local needs are met

+ Inform the relevant internal stakeholders about the regulatory authority's approval of changes to the packaging component(s) for the assigned products

+ Link with the Product Quality Manager for timely implementation of the approved labelling-associated artworks

+ Handling with all relevant global databases and systems and other applications

+ Keep updated the local registration tracking of all new/ongoing applications, renewals and variations

+ Monitor the progress of applications against the set timelines, taking action when necessary

+ Contribution in managing Pfizer's relationship with the authorities

+ Provide support in the development, implementation and maintenance of the local procedures

+ Apply a risk management approach

**What you offer:**

+ Life science, medical science, pharmaceutical or chemistry graduate.

+ Appropriate Regulatory Experience

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

+ Excellent verbal and written communication skills in both local and English (written and spoken)

+ Excellent time management

+ Proficiency with computer and software applications (i.e. Microsoft Office)

+ Ability to work independently as well as part of a team

**In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture.**

**Please apply in English documents 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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