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.

Date Posted

31-Oct-2024

Closing Date

29-Nov-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.