EU Regulatory Strategy Manager / Liaison

Recruiter
Pfizer
Location
Tadworth
Posted
03 Aug 2017
Expires
19 Aug 2017
A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Role Summary Serve as EU Regulatory Lead on multifunctional project teams in the oncology therapeutic area, providing regulatory expertise to teams. Develop and deliver regulatory strategies for Phase 1 through Phase 4 development stages. Manage all regulatory aspects of projects, including the preparation and submission of correspondences and applications to regulatory agencies. Act as direct liaison with EMA and other Health Authorities to facilitate the prompt review and approval of applications. Understand regulatory environment and communicate priorities to stakeholders. Responsibilities •Accountable for leading the preparation of EU Regulatory Strategies and implementation plans (core labels, risk registers) for assigned projects. •Partner with project teams and other customers (e.g., Oncology Research Unit/Pfizer Oncology, Regional Commercial Teams) to ensure regulatory contributions (EU Regulatory Strategies, labels, CTAs, MAAs, variations, etc.) meet business needs and are provided within agreed time, cost and quality standards. •Develop and maintain constructive working relationship with Health Authority contacts. •Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated. •Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards. •Ensure business compliance, and implementation of and adherence to regulatory standards. Qualifications •BS or higher degree advantageous •Prior oncology drug development experience preferred. Immuno-oncology experience beneficial. •Proven examples of delivery with demonstrable contribution in EU Regulatory activities, including knowledge of CTA, MAA and other submission processes. •Proven ability to manage complex regulatory issues. •Proven ability to consistently deliver within time, cost and quality standards. Closing date for applications: 31.7.17 Working location: UK (Walton Oaks or Sandwich) or Milan, Italy To apply please visit www.pfizer.com/careers and search for job ID 1607047. This job was originally posted as www.totaljobs.com/job/75181873