Early Phase, Eu Regulatory Strategy Sr. Associate Milano

Early Phase, Eu Regulatory Strategy Sr. Associate
Milano
Lombardia, Milano

Early Phase, EU Regulatory Strategy Sr.

Associate We're in relentless pursuit of breakthroughs that change patients' lives.

We innovate every day to make the world a healthier place.

To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Key Responsibilities: Represent EU region (EU, UK, CH, NZ, AUS) for regulatory sciences in relation to the designated early-stage oncology portfolio.

Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).

Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the company goals.

Accountable for timely submissions and approvals in the EU region.

Ensure optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU.

Additional Responsibilities: Ensure EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned early-stage oncology portfolio.

Achieve objectives in the strategy, meet agreed standards, maximize overall project delivery time, and facilitate submission activities.

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.

Monitor regulatory plans, communicate progress/variance to GRL and Senior Management, and mitigate risks.

Ensure an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s.

Engage in activities to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations.

Ensure business compliance and adherence to Regulatory standards.

Develop and maintain constructive working relationships with Health Authority contacts in the EU region.

Organizational Relationship: Reports to early phase Oncology EU lead.

Works with GRS colleagues and relevant project team(s) members.

Partners with EU colleagues to provide an EU position.

Works with external contacts in Regulatory Agencies within EU region.

Ensures alignment with GRL and early phase Oncology Global Head.

Minimum Qualifications: Scientific Degree; a higher degree may be an advantage but is not essential.

1-3 years of experience in managing national and/or EU regulatory processes of drug development, particularly clinical trials experience in at least one country.

Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas is highly desirable.

Experience in communicating with major EU regulatory agencies and leading such interactions is preferred.

Knowledge of drug development practice rules, regulations, and guidelines.

Proven ability in developing and implementing regulatory strategy.

Strong communication skills, both verbal and written, to convey complex information to various audiences.

Effective presentation skills in various formal settings.

Negotiation skills to manage tough situations effectively.

Fluency in English is essential.

Deadline to apply: Jan 7, 2025 This is a permanent, full-time position.

Pfizer's current working arrangement is a flexible 2. 5 days/week on site.

Purpose: Breakthroughs that change patients' lives.

At Pfizer, we are a patient-centric company, guided by our values of courage, joy, equity, and excellence.

Flexibility: We aim to create a trusting, flexible workplace culture that encourages employees to achieve work-life harmony.

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

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