The Associate Regulatory Affairs Director (ARAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned products 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 be accountable to provide regulatory input to Global Program 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:

• Developing and implementing global regulatory strategies for assigned products.
• Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
• Providing 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.
• May 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 being 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 AstraZeneca’s internal knowledge and expertise
• Ensuring exemplary behaviour, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Qualifications

• 7+ 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 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 time-sensitive fashion.
• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.
• 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 guidance’s. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.

Education

• Bachelor’s 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