Global Regulatory Affairs Oncology Jr Associate
Job posting number: #7115558 (Ref:pf-4869900)
Posted: November 7, 2022
Application Deadline: Open Until Filled
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.
- 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
- 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
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