Senior Director, Regulatory Affairs

BeiGene

About The Position

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. General Description: The Senior Director, Canada, will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure approval and maintain market access for product(s) in line with business objectives, with a focus on developing these capacities in Canada in coordination with the BeOne affiliate. The role is responsible for management of the regulatory aspects of products and/or therapy lifecycle within Canada, including clinical trials. The incumbent in the role acts as a leading partner within the full chain of value creation who understands the current healthcare environment and anticipates how relevant market dynamics may impact how company products and offerings are used. This individual will facilitate regulatory interactions with health authorities for BeOne assets through all phases of development, post-approval, and lifecycle. The incumbent will provide strong leadership and considered strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The individual has departmental and corporate-level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy. They will provide line management, people development, and performance management as well as support/lead development and implementation of department policies

Requirements

BA / BS in Health Sciences, with a minimum of 12+ years of regulatory strategy experience in the pharmaceutical industry required.
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint
Must be willing to travel approximately 10-20%

Responsibilities

Responsible for management of the regulatory aspects of a product(s) or therapy(s) life-cycle within Canada.
Ensure strategic input into the global plan, to ensure that specific Canadian needs are met for successful launch and implementation of products, offerings or therapeutic areas.
Enhance patient-centric approach integration in each product LCM.
Ensure the scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups in Canada.
Provide scientific communication to all key stakeholders in Canada.
Collaborates with Canadian Business and Global Regulatory Affairs Management on relevant long-term regulatory objectives and concerns.
Develops strategies to ensure effective achievement of regulatory/business objectives.
Oversee and participate in the preparation and submission of NDS/sNDS, CTA/CTA-A applications and routine reports/renewals and work with Health Canada to obtain earliest possible product and clinical trial approvals.
Responsible for review of sections of IND/CTA, NDA/MAA/NDS, and other global and local submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
Responsible for assisting with the development and implementation of regulatory processes.
Responsible for serving as the regulatory business partner to local commercial and medical activities supporting the Canadian affiliate in these areas.
Active member on affiliate Canadian Leadership Team and provides guidance and advice to Canadian Business as well as Global Regulatory Management to achieve goals related to financial goals, regulatory schedules, processes, and methods.
Provides advice on regulatory issues that affect the business of the company.
Represents the company to outside customers and agencies and makes presentations on regulatory issues.
Serves as company point person to work through our industry associations or directly with Health Canada to help steer regulatory policy.
Instrumental in obtaining regulatory product approvals and improving the regulatory environment in Canada.
Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
Serves as the regulatory representative for Canadian PRC and MRC reviews to ensure submitted materials are in compliance with applicable regulatory agency regulations and guidelines.
Serves as the point person for all Health Canada regulatory and quality and compliance related company communications.
Works with cross-functional teams to ensure legal, compliance and technical requirements are met.
Recruits, Trains, develops, and manages an effective Canada regulatory team.
Establish a compelling vision with clearly focused priorities by translating the sector’s strategies into individual priorities and goals.
Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans.
Complete performance review activities for all direct reports as per the established corporate guidelines and practices.
Develop and maintain current regulatory knowledge and ensure that the staff is aware of new and existing regulatory procedures and changes.
Ensures compliance with Canadian pharmacovigilance regulations, including the reporting of adverse drug reactions and product quality complaints