Global Regulatory Affairs Oncology Jr Associate

Pfizer Inc.

Milan, Italy

Job posting number: #7115558 (Ref:pf-4869900)

Posted: November 7, 2022

Application Deadline: Open Until Filled

Job Description

Pfizer is excited to present an opening for an enthusiastic, talented, dynamic, international mind-set and motivated Global Regulatory Affairs Oncology Jr Associate within the Global Regulatory Affairs department – Site of Milan. Fixed Term Contract: 12 months.

The purpose of this role is to:

  • Work with GRA oncology colleagues supporting key regulatory tasks and deliverables across programs for regulatory affairs, starting with EU regulatory region
  • Support regional regulatory strategies in implementing activities of in agreement with Global Regulatory Lead (GRL) and other key stakeholders for assigned projects/products
  • Accountable for timely  preparation  and, submissions  of program(s) deliverables in the EU to obtain regulatory approvals  
  • Role can be combined with other GRA function activities based upon priorities.
  • Project(s) assigned can be in early development/registration and/or at post-authorization stage across oncology.

Job Responsabilities:

  • Work across programs to support CTA  preparation and submission activities, regulatory systems updates and compliance, regulatory correspondence archiving, support RL in the coordination of rapid response team activities
  • Ensures  regulatory plans of assigned projects are monitored and  progress/variance communicated to GRL/RL  as well as  inform of them of any risks (from emerging technical data, changing internal objectives or external threats) to be mitigated
  • Contribute to develop and achieve alignment on the EU   regulatory positions for any key issues for assigned projects by closely working with Regulatory strategist  and relevant Team memberse
  • Ensures business compliance and implementation of and adherence to Regulatory standards

Requirements:

  • Bachelor’s degree in a science-related field, Pharmacy, CTF or equivalent
  • Experience in regulatory, or in clinical or scientific research is an advantage but not a requirement.
  • Due to the international environment, fluent English in comprehension, reading and speaking skills is a requirement.
  • Knowledge of drug development practice rules, regulations and guidelines - familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines
  • Oncology regulatory experience and/or internship preferred
  • Career aspiration in developing and implementing regulatory strategy – Basic understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or NDAs/BLAs desirable. Understanding of key concepts of product label aligned to target product profile and corporate expectations.
  • Italian and english
  • Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management
  • Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers Negotiation skills - Can negotiate skillfully and diplomatically in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations

Work Location Assignment: Flexible

Deadline to apply: Nov 9, 2022

Purpose 

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.

Flexibility  

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.

Regulatory Affairs

#LI-PFE


Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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More Info

Job posting number:#7115558 (Ref:pf-4869900)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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