Executive Director, Head of Regulatory Affair New

General Description

Responsible for strategic and operational regulatory support of BeiGene’s entry into our new market territories worldwide, with dotted reporting line to the Head of New Markets (i.e. LATAM, MENA, Eastern Europe and Africa). Accountable for managing the assigned regulatory affairs teams to drive the regulatory activities of all BeiGene portfolio in New Market (NM) territories. Provides strategic regulatory leadership to the cross-functional NM management Team to share accountability for successful commercialization of the new product and subsequent LCM

Essential Function of the Job:

- Responsible for defining and implementing regulatory strategies and submissions in support of new and existing products in BeiGene NM territories (i.e. LATAM, MENA, Eastern Europe and Africa)
- Interfaces with internal and external resources, to understand complex national and regional regulatory requirements for both pre-marketing and post-marketing phases. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes, interprets regulations, gives regulatory insight, advice and support to cross-functional teams
- Responsible for highlighting potential issues/delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with Global Regulatory Teams and other cross-functional teams to assist in problem solving.
- Works collaboratively and closely with the NM commercial teams to generate, evaluate and deliver robust commercial options and strategies for development programs including defining the range of LCM investment options/business cases and making recommendations for /decision on investment, in order to maximize the value of the Brand’s portfolio to BeiGene
- Evaluate current regulatory processes/procedures and identify and implement improvements, especially for NM territories
- Ensures appropriate Governance and Compliance and protects BeiGene’s Rights, Data and Intellectual Property

Other Qualifications/Requirements:

- Bachelor’s degree or higher in a scientific, medical or healthcare discipline with minimum of 20 years of experience in regulatory affairs function
- Extensive hands-on experience in international regulatory affairs for Rx products
- Proven ability to effectively work in a global, cross-functional matrix organization. Ability to work effectively in diverse cultures, showing aptitude in modifying style
- Proven track record in managing a RA team
- Experience in working with a portfolio of brands in a variety of markets, with adaptation to different cultures and needs
- Strong communication, organizational, negotiation and interpersonal skills.
- Ability to effectively communicate with upper management, affiliates, regulatory agencies, and industry associations to ensure that regulatory and business needs are met is required.
- Flexibility to provide innovative approaches to gain marketing approvals
- Strategic and Decisive Leader - leadership skills that demonstrate energy, passion, courage, vision and demonstrated competence in thinking strategically, analytically and innovatively. Able to quickly and creatively analyze and provide solutions to complex challenges. Proven experience as a successful decisive leader in a strategic multifunctional environment.
- Experience with global regulatory submissions and interacting with major health authorities; NDA and/or BLA submission experience strongly desired

Supervisory Responsibilities:

- Manages the RA team responsible for NM territories
- Provides line management to direct reports, including professional development,
- performance appraisals and employee counseling/mentoring.
- Oversees line management of indirect reports ensuring their professional and career

development needs are being met by their FM. Coach the FM as required.
- Oversees performance of direct and indirect reports and anticipates performance issues, implementing recovery strategies as soon as possible and if not successful, lead or support the Performance Improvement Plan or disciplinary procedures as appropriate in conjunction with HR.
- Manages and coordinates resources including the review of workloads of direct reports and the wider team as required.

Education/Experience Required:
Bachelor’s degree or higher in a scientific, medical or healthcare discipline with minimum of 15-20 years of experience in regulatory affairs function

Computer Skills: Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Location: Remote, ideally US EST time zone

Travel Required: Meetings/conferences, face to face team meetings.

Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.