Senior Director, Global Regulatory Lead, COVID-19 Vaccine

Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Please Note: This is a Clinical Regulatory Affairs position, not a CMC/Facilities Regulatory Affairs position. The candidate must be able to provide operational and strategic Regulatory leadership and contribution to the areas of global clinical development, registration plans, labelling, licensure, and post-marketing commitments/post-authorization safety surveillance.

ROLE SUMMARY

• Provide strategic regulatory expertise as Global regulatory representative to Product Team(s).
• Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.
• Through the GRST, develop, align, manage and implement the global regulatory strategy.
• Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs.
• Be accountable for timely submissions and approvals with commercially attractive labelling across the regions.
• Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).
• Role may be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).
• Project(s) assigned can be in development and/or at post-authorization stage

ROLE RESPONSIBILITIES

• Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.
• Provides regulatory expertise and leadership for the project/product.
• Member of appropriate Project(s)/Product(s) teams.
• In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.
• Ensures appropriate representation for Pfizer for the project/product with Health Authorities.
• Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.
• Ensures that all regulatory development process commitments are clearly communicated, monitored and met.
• Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy
• Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.
• Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.
• Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.
• Participates in appropriate governance committees, as necessary.
• This is a people manager role.
• Location: Brussels (Belgium).

Your qualifications

• BS is required. MS, PharmD, or PhD preferred. 15 years of relevant work experience required.
• Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.
• Advanced knowledge of US FDA and EMA regulations required, advance knowledge also including additional global Health Authority regulations preferred.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Our offer

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. Pfizer’s open-door policy is an integrated part of our culture across all levels of seniority.

We offer possibilities for working from home (up to 3 days per week) and flexible working hours.

Competitive salaries and benefit packages including meal vouchers, DKV hospitalisation, outpatient, dental, pension plan, phone, company car. 29 days off.

Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…

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.

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