Senior Regulatory Affairs Director (Rare Diseases)

This is what you will do: 

The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development 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 Teams 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 AstraZeneca’s internal knowledge and expertise. 

• Can provide support as needed to Business Development activities of the Enterprise, notably supporting Regulatory due diligence, gap assessment and resource needs. 

• Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders. 

You will need to have: 

[Definition: Essential Qualifications. The minimum skills and requirements needed for the position]