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Regulatory Affairs Officer

Pfizer


Location:
Lisbon, OH 44432
Date:
11/25/2017
2017-11-252017-12-26
Pfizer
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Job Details

**ROLE DETAILS**







**ROLE SUMMARY**



All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.







Colleagues applying for this role must be PCO based and will contribute to lead, manage and provide strategic direction to develop and execute regulatory strategies and plans for the country and/or products under his/her responsibility, where applicable, assuring a successful execution of the regulatory strategy and maintenance of the products during their complete lifecycle, in full compliance with Pfizer Global Polices and local current Regulations.







**ROLE RESPONSIBILITIES**



The major duties and responsibilities will include, but are not limited to:







+ Identifying, implementing and managing key RA Departmental/Therapy Area projects either on an individual basis or as part of the RA Management Team, based on both short and long term RA Department objectives.



+ Actively contribute to the fact that the RA Department has effective and efficient processes in place. This includes (but it is not limited to) interactions with HUBs (Labeling, Submission and CMC).



+ Responsible for system data updates



+ To participate in/lead, cross-functional project teams, to address business needs in line with business objectives and strategic imperatives.



+ To monitor regulatory activities related to his/her specific therapy area in accordance with reporting lines and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements.







**QUALIFICATIONS**



Pharmaceutical degree (preferably) or life science degree







+ Previous regulatory experience required, preferably



+ Portuguese native speaker



+ Fluency in Portuguese and English, both written and spoken, is essential



+ Strong quality and compliance orientation. Has an understanding of regulatory compliance issues and the potential impact of compliance related issues on meeting business objectives.



+ Good written and verbal communication skills



+ Time management skills



+ Ability to work independently and as part of a multidisciplinary team



+ Analytical skills







Good Computer skills - Word, PowerPoint and basic Excel







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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