Regulatory Affairs Group Director (RAGD) Regulatory Science & Execution Global Regulatory Affairs

This is what you will do: 

The Senior Regulatory Affairs Group Director (RAGD) will be responsible for overseeing, leading and managing execution teams and/or regional regulatory strategists, 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, provide people leadership and regulatory input to the Regulatory organization, ensuring teams develop, perform and execute at the best possible level. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities. 

You will be responsible for: 

• Oversees regulatory staff responsible for developing and implementing strategies and executing for products and/or projects in the relevant regulatory jurisdictions, as assigned, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management. 

• Accountable for the people management of regulatory execution and/or regional strategists teams, actively collaborating with other Regulatory functions to deliver on talent and resource needs for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.). 

• Accountable as a Leader for the assigned regulatory team(s), collaborating with the Global and Regional regulatory cross-department Leaders  to ensure activities and deliverables are resources, distributed in a balanced manner and performed effectively. 

• Oversees the work of execution and regional strategy teams in the planning and conduct of regulatory authority meetings in relevant jurisdictions, 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.  

• Supports provision of advice and input from execution and regional strategy teams 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 regional 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. 

You will need to have: 

Qualifications 

• 12+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies (e.g. EU, US, China, Japan). 

• Strong knowledge of drug development and regulatory policy, couple by excellent scientific and business judgment. 

• Experience providing leading and managing cross-skilled regulatory staff to deliver on business objectives, in mentoring and developing staff. 

• 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. 

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