Regulatory Affairs Director, Global Regulatory Strategy

AstraZeneca • Gaithersburg, MD

32d • Hybrid

About The Position

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 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. You will be responsible for:

Requirements

• 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 pre-approval 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 time-sensitive fashion.
• Ability to build intra- and inter-team 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.
• Bachelor’s Degree, life science highly desirable
• Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
• Proficient in English in the Corporate setting.

Nice To Haves

• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
• Additional certification and/or training relevant to the role over the past
• Additional languages are a plus

Responsibilities

• 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 AstraZeneca’s internal knowledge and expertise.
• Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.

Benefits

• 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.
• Competitive salary and benefits package on offer.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees