Undergraduate Rare Disease Reg Strategy
Undergraduate – Rare Disease Regulatory Strategy
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 their life cycle such as, undergoing clinical trials as part of development or being further developed while on the market. The regulatory strategy representative will advise and coordinate the efforts of the project teams and manage Pfizer’s interactions with European health authorities to ensure that;
1) new products are made available to patients as soon as possible, and
2) maintain Pfizer’s marketed products to the highest standards of safety, efficacy and compliance.
The Global Regulatory Affairs (GRA) Regulatory Strategy team is involved with a great diversity of therapeutic areas (e.g. Rare Disease, 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 Industrial Trainee has responsibility for
Day to day provision of support in the compilation of general regulatory project documents and strategies, 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 with products at all stages of development. Regulatory Strategy is an essential discipline to drug development where change is the norm, so you would need to be a good communicator, flexible and well organised.
MAJOR DUTIES AND RESPONSIBILITIES
Contribute to Global Regulatory Strategies and implementation plans, ensuring an aligned EU position is reached and agreed for assigned project/sMonitor progress/variance of regulatory plans and communicate as necessary ensuring identified risks are addressedHelp to maintain systems, processes and procedures relating to regulatory strategy, ensuring that these facilitate the sharing of information across PfizerEngage 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
Breakthroughs that change patients’ lives … At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
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