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Undergraduate European Regulatory Strategist

Pfizer


Location:
Augusta, GA 30901
Date:
01/26/2018
2018-01-262018-02-26
Pfizer
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Job Details

**Undergraduate European Regulatory Strategist**



Worldwide Safety and Regulatory - Europe







Regulatory Strategy







**Department Overview**







The prime function of Pfizer's regulatory strategy department (based in Walton Oaks, UK) is to provide advice to drug development teams and product management teams to ensure Pfizer meets the requirements of global health authorities. The regulatory strategy department also manages the interactions between Pfizer and the health authorities. A regulatory affairs professional in Pfizer therefore has a unique overview of the company, seeing a product from research stages, through clinical development and onto the market.







**What can I achieve and what will I be responsible for whilst completing a placement at Pfizer?**







It is the responsibility of the Regulatory Strategy representative for Europe, to lead and implement regulatory strategies for medicinal products within Europe. Products can be at any stage in the life cycle such as, undergoing clinical trials as part of its development or being further developed while on the market. The regulatory representative will advise and coordinate the efforts of the project teams and manage Pfizer's interactions with European health authorities to ensure that:







+ New products are made available to patients as soon as possible



+ Pfizer's marketed products are maintained to the highest standards of safety, efficacy and compliance







The group is involved with a great diversity of therapeutic areas (e.g. Oncology, Cardiovascular, Neuroscience) and includes a broad spectrum of activities throughout the life cycle of pharmaceutical products (research, clinical development and marketing).







During the year, an Undergraduate has responsibility for:







+ Day to day provision of support in the compilation of general regulatory project documents, clinical trial applications, regulatory dossiers and responding to regulatory questions received from health authorities.



+ Managing multiple projects, of benefit to the company.







This position is based in a busy worldwide regulatory strategy group. This is a discipline where change is the norm, so you would need to be both flexible and well organised.







+ Contribute to Global Regulatory Strategies and implementation plans, ensuring an aligned EU position is reached and agreed for assigned project/s.



+ Monitor progress/variance of regulatory plans and communicate as necessary ensuring identified risks are addressed .



+ Help to maintain systems, processes and procedures relating to regulatory strategy, ensuring that these facilitate the sharing of information across Pfizer.



+ Engage in appropriate activities to help influence the regulatory environment through health authority interactions and Trade Associations.



+ Develop and maintain constructive working relationships with health authority contacts.







**What other opportunities and benefits do Pfizer offer?**







+ A year's experience working in one of the highest priority and greatest growth areas within the company that has a drug development pipeline envied by many other pharmaceutical companies.



+ Knowledge of regulatory affairs together with an understanding of how this enhances the Research & Development and commercial aspects of the business.



+ Appreciation and working knowledge of European regulatory affairs coupled with specialist knowledge in your project area.



+ The satisfaction of being a part of the team that helps to deliver new products as speedily as possible to where they are needed - the patients.



+ A Pfizer placement can offer a stepping stone into the pharmaceutical industry in a company that has consistently been ranked amongst the top 100 graduate employers







**When can I start?**







Placements will start on 3rd September 2018 and will run for 12 months.







**PERSON SPECIFICATION**







Type of person we are looking for, in relation to ' **Skills** ', ' **Knowledge** ' and ' **Motivation** ':







+ On target for a 2:1 Degree Classification



+ Good communication, negotiation and interpersonal skills



+ Ability to build networks and alliances with peers



+ Comfortable working on their own and in a wide range of team roles



+ Can view issues from different angles and can project future impact



+ Willing to challenge



+ Can analyze and synthesize complex data into simple messages and actions going forward



+ Proficient in the use of Microsoft Office suite of programmes







**Please note that we only accept application forms. Please do not send over your CV or cover letter as they will not be considered.**







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