Regulatory Affairs Director Global Regulatory Strategy
Regulatory Affairs Director Global Regulatory Strategy
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$ 186232 - 279349
1 Vacancy
Job Description
Position Summary:
The Regulatory Affairs Director (RAD) Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned products and therapeutic areas with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
This individual will with a high sense of urgency lead crossRegulatory 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.
You will be responsible for:
- Accountable to develop and oversee global regulatory strategies in the defined therapeutic area or portfolio.
- Provide regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio as assigned aligned to overall Enterprise objectives 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. May represent Alexion as point 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.
- Actively be up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZenecas internal knowledge and expertise.
- Ensure exemplary behavior leadership ethics and transparency within the Enteprise with Health Authorities and other external stakeholders.
You will need to have:
- 8 years of Regulatory experience in the pharmaceutical industry with significant track record on Global Strategies.
- Strong knowledge of drug development and regulatory policy coupled by excellent scientific and business judgment.
- Experience providing strategic regulatory advice for the global development of products through all stages of development including preapproval and marketed assets.
- Successful track record in registering and overseeing regulatory strategies for assets.
- Ability to manage complex issues and coordinate multiple projects simultaneously in a timesensitive fashion.
- Ability to build intra and interteam relationships and collaborate in a global team environment at all levels of the organization especially Senior Management.
- Strong interpersonal and written/verbal communication skills.
- Proven track record practicing sound judgment as it relates to risk assessment
- Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
Education
- Bachelors Degree life science highly desirable
- Postgraduate degrees relevant to the role e.g. MSc PhD) a plus
- Additional certification and/or training relevant to the role over the past
Competences
- Excellent use of Microsoft 365 (Office) tools ideally well skilled on the use of PowerPoint
- Proficient in English in the Corporate setting. Additional languages are a plus
Why AstraZeneca
At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.
So whats next
Are you already imagining yourself joining our team Good because we cant wait to hear from you!
Competitive salary and benefits package on offer.
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 facetoface in our offices 3 days a week.
The annual base salary for this position ranges from $186232..20. However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm 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 atwill 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
07Apr2025Closing Date
29Apr2025Alexion 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 Alexion participates in EVerify.Required Experience:
Exec
Employment Type
Full-Time
