Associate Regulatory Affairs Director

The Associate Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance ofregulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achievingsuccessful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

This individual willprovide tactical and strategic input to and leadership acrossregulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. 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 for theregulatory execution of submissions in the relevant regulatory jurisdiction(s), by actively collaborating with other Regulatory functions and cross-functional teams(e.g.clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.).
• Responsible for managing and implementing registration and post-marketing activities related to US Prescribing Information, Patient Package Inserts, Medication Guides, Instructions for Use, and labeling artwork as applicable. Duties include collaborating with US Regulatory Strategists and cross-functional teams to develop and maintain accurate, FDA-compliant labeling content.
• 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 AstraZeneca’s internal knowledge and expertise.
• Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support.
• Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in mentoring, and performance feedback to regulatory and cross-functional colleagues.
• Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Qualifications:

• Bachelor’s Degree, life science

• ​Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus

• 7+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in regional regulatorystrategies (e.g. EU, US, UK, Canada).

• Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment.

• Experience providing strategic regulatory advice in at least oneseveralregulatory jurisdiction(s) (e.g.EU, US, Canada, UK) for the global development of products through most stages of development, with a focus on marketed assets.

• Ability to manage complex issues and lead 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, including Senior Management.

• Strong interpersonal, written/verbal communication and presentation 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 GxPsat relevant areas and solid understanding of where to seek and how to interpret regulatory information.

• Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint

• Excellent use of artwork management system and Trackwise

• Experience working in regulatory documentation system (like Veeva)

• Proficient in English in the Corporate setting. Additional languages are a plus 

• Additional certification and/or training relevant to the role

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives. Ready to make a difference? Apply now!