Senior Associate, Early Phase, Regulatory Affairs Specialist

4 settimane fa

Milano, Lombardia, Italia Pfizer, S.A. De C.V A tempo pieno
Job Title: Senior Associate, Early Phase, Regulatory Affairs

About Us:

Pfizer is a patient-centric company guided by our four values: courage, joy, equity, and excellence. We are dedicated to transforming millions of lives through our breakthrough culture.

Job Summary:

We are seeking a Senior Associate, Early Phase, Regulatory Affairs to join our team. The successful candidate will be responsible for representing the EU region for regulatory sciences in relation to the designated early-stage oncology portfolio.

Key Responsibilities:
  1. Represent the EU region for regulatory sciences in relation to the designated early-stage oncology portfolio.
  2. Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
  3. Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals.
  4. Accountable for timely submissions and approvals in the EU region.
  5. Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU.
  6. Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolio.
  7. Ensure regulatory contributions, achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating submission activities.
  8. Partner with project teams to ensure required regulatory contributions (CTA, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
  9. Ensure regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
  10. Ensure an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the EU business are championed and communicated.
  11. Engage in appropriate activities in order to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.
  12. Ensure business compliance and implementation of and adherence to Regulatory standards.
  13. Develop and maintain, directly or indirectly, constructive working relationship with Health Authority contacts in the EU region.
Requirements:
  1. Scientific Degree.
  2. A higher degree may be an advantage but is not essential.
  3. Proven experience in managing national and/or EU regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country.
  4. Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable.
  5. Experience in communicating with major EU regulatory agency(ies) respectively, as well as participating in/leading such interactions, is preferred.
  6. Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
  7. Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines.
  8. Experience preparing and submitting CTAs.
  9. Strong 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.
  10. Effective presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior manager.
  11. Strong negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups.
About Pfizer:

Pfizer is a patient-centric company guided by our four values: courage, joy, equity, and excellence. We are dedicated to transforming millions of lives through our breakthrough culture.

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.

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating diversity, in all its forms – allowing for us to be as diverse as the patients and communities we serve.

We are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates.

We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career.

Your journey with Pfizer starts here.

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