Senior Regulatory Affairs Director

As a
Senior Regulatory Affairs Director
you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. R&D Biopharma drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

What you\’ll do

:As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. You will show strategic leadership skills, and a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs

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You will lead the planning and construction of the global dossier and core prescribing information. You will conduct regulatory risk planning and mitigation. You will leads the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement. You will be accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures. You will be accountable for product maintenance, supply and compliance activities associated with marketed brand

s.

You will lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. You will partner with marketing company and regional regulatory affairs staff to influence developing views/guidance. You will lead the regulatory staff working, provide leadership and participate in skill-development, coaching, and performance feedba

**ck.

Essential Requireme**

• nts:Advanced degree in a science related field and/or other appropriate knowledge/experie
• nce.Must have previous experience in leading Major Health Authority interacti
• ons.Significant experience or equivalent of regulatory drug development including product approval/lau
• nch.Expert knowledge of regulatory affairs within one or more therapeutic ar
• eas.Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affa
• irs.Experience in relevant therapy area (small molecules & biologics) is prefer
• red.Proven leadership and program management experie
• nce.Ability to think strategically and critically evaluate risks to regulatory activit
• ies.Ability to work strategically within a complex, business critical and high profile development prog
• ram.Successful contribution to a major regulatory approval at a global le
• vel.A scientific and clinical understanding of the regulatory scien
• ces.Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication ski

lls.