Vice President, Regulatory Affairs, Europe and International

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
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* General Description:

** The Vice President, Europe and International Regulatory Affairs (APAC and New Markets, excluding USA, China and Japan), is a leadership position that will be responsible for building and leading the regulatory groups to develop and implement regulatory strategies to secure and maintain market access for product(s) in line with business objectives and in coordination with key internal stakeholders. The incumbent will provide leadership and strategic regulatory oversight for BeOne/Beigene projects ensuring that the latest regulatory requirements and standards are met.

The individual has departmental and corporate level responsibility for regulatory strategy, will sit on the GRA leadership team and represent regulatory on the European cross functional leadership team. Externally, the individual will interface with EMA, national regulators and international organizations regarding drug development and registration strategies and provide insights to the organization of evolving regulatory policy and its impact to BeOne/Beigene’s business.

He/She also has line management, people development, and performance management responsibility across a broad geographic area.
** Essential Functions of the job:
*** Establishes, develops, and manages effective/high performance regulatory groups and teams both via direct and indirect reporting structure
* Builds partnerships with key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and expertise
* Establishes and maintains a trusting relationship with the Regulators by enforcing transparency in communications and ensuring compliance with national regulations
* Leads the regulatory team by creating a supportive environment that enables and empowers team members to collaborate and deliver high quality work
* Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to, general regulatory strategies, regulatory requirements for clinical studies and Marketing authorizations, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interaction strategies.
* Applies extensive knowledge of drug development and regulatory requirements both strategically and operationally to development projects and marketed products to support corporate goals and improve global regulatory processes.
* Maintains up-to-date regulatory knowledge, state-of-art regulatory science, and deep understanding of regulatory policy globally, and assesses the impact on business and product development strategy.
* Ensures RA’s contribution to high quality of CTA’s and MAA’s in conformance with national regulatory requirements, and to the timely submission and approvals
* Support the establishment of new affiliates aligned with BeOne/Bei Gene’s geographic footprint.
* Support the development and execution of local country regulatory strategy and life cycle management.
* Leverages new technologies and regulatory mechanisms to enable efficient submissions with a fungible team that supports the local markets robustly with new and evolving processes to be defined.
** Core Competencies, Knowledge & Skill Requirements:
*** Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends in Europe and other markets, preferably with a strong oncology focus.
* Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
* Strong business acumen and ability to make sound decisions that contribute positively to the business
* Very strong strategic skills…