Senior Regulatory Affairs Director, Global Regulatory Strategy

Position Summary:

The Senior Regulatory Affairs Director (RAD), a member of the Global Regulatory Strategy team, will be responsible for overseeing the development, implementation, and execution of regulatory activities for assigned products and regulatory jurisdictions with a goal of achieving registrational approval from governmental authorities and post approval life cycle management.  

The successful candidate will lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

Primary Responsibilities:

• Provide strategic regulatory oversight for products and/or projects in the relevant therapeutic areas/portfolio, as assigned, through initial registration and subsequent lifecycle management
• Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents
• Represent Alexion, where necessary, as point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders
• Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise
• Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise
• Proactively stay abreast of the latest regulatory requirements and trends, and ensure information is shared with members of Regulatory Affairs department to assist with the shaping of the regulatory science environment
• Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and expertise
• Support Business Development, where necessary, providing Regulatory due diligence, gap assessments and resource need requirements

Qualifications

• Bachelor’s degree in a scientific or regulatory affairs with at least 10 years of regulatory experience in the pharmaceutical industry, with a significant track record in global strategy
• Postgraduate degree in relevant discipline (e.g. MSc, PhD) is a plus
• An understanding of regulatory processes and regulations, across all stages of drug development (preapproval, authorization and post marketing)
• Experience providing strategic regulatory advice for the global development of products in several major jurisdictions such as EU, US, China, Japan through all stages of development including pre-approval and marketed assets
• Successful track record in registering and overseeing regulatory strategies for assets
• Experience managing orphan drugs is a plus
• Experience contributing to Advisory Committee activities is a plus
• Knowledge of device regulations is a plus
• Ability to manage cultural differences and work effectively in diverse teams
• Ability to manage multiple stakeholders and build team relationships to collaborate in a global team environment at all levels of the organization
• Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organization 
• Excellent written and verbal communication skills
• A proven track record of leadership and project management in regulatory affairs is required
• Strong strategic and technical regulatory knowledge, with long-term and global vision

The duties of this role are generally conducted in an office environment.  As is typical of an office based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

The annual base salary for this position ranges from $207,658 to $311,488. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.