Alexion
Regulatory Affairs Director, Global Regulatory Strategy
Alexion, Gaithersburg, Maryland, us, 20883
Overview
Position Summary:
The Regulatory Affairs Director, Global Regulatory Strategy (RAD), will be responsible for the development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the aim 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: 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, 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 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. 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. Stay up to date on latest regulatory requirements and trends, and contribute to shaping the regulatory science environment. Support regulatory intelligence and policy priorities based on internal knowledge and expertise. Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders. Qualifications
You will need to have: 8+ years of regulatory experience in the pharmaceutical industry, with a significant track record on global strategies. Strong knowledge of drug development and regulatory policy, coupled with 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 ability to seek and interpret regulatory information. Education
Bachelor’s Degree, life sciences 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 years. Competences
Excellent use of Microsoft 365 (Office) tools, with strong PowerPoint skills. Proficient in English in the corporate setting. Additional languages are a plus. Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. We empower you to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. We foster an inclusive culture that champions diversity and collaboration, and are committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. What’s next?
Are you ready to join our team? We can’t wait to hear from you! Competitive salary and benefits package on offer. We offer flexible ways of working to balance personal and work commitments, including collaborating face-to-face in our offices 3 days a week. The annual base salary for this position ranges from $186,232.80 - 279,349.20. Base pay offered may vary depending on market location, job-related knowledge, skills, and experience. The position may include a short-term incentive bonus opportunity; eligibility to participate in an equity-based long-term incentive program or retirement contribution for salaried/hourly roles. Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and health benefits (medical, prescription drug, dental, vision). Details of participation in benefit plans will be provided if an offer is made. At-will employment status and Company right to modify compensation are reserved. Date Posted:
10-Sept-2025 Closing Date:
14-Sept-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. We welcome applications from all qualified candidates, regardless of protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Position Summary:
The Regulatory Affairs Director, Global Regulatory Strategy (RAD), will be responsible for the development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the aim 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: 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, 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 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. 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. Stay up to date on latest regulatory requirements and trends, and contribute to shaping the regulatory science environment. Support regulatory intelligence and policy priorities based on internal knowledge and expertise. Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders. Qualifications
You will need to have: 8+ years of regulatory experience in the pharmaceutical industry, with a significant track record on global strategies. Strong knowledge of drug development and regulatory policy, coupled with 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 ability to seek and interpret regulatory information. Education
Bachelor’s Degree, life sciences 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 years. Competences
Excellent use of Microsoft 365 (Office) tools, with strong PowerPoint skills. Proficient in English in the corporate setting. Additional languages are a plus. Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. We empower you to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. We foster an inclusive culture that champions diversity and collaboration, and are committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. What’s next?
Are you ready to join our team? We can’t wait to hear from you! Competitive salary and benefits package on offer. We offer flexible ways of working to balance personal and work commitments, including collaborating face-to-face in our offices 3 days a week. The annual base salary for this position ranges from $186,232.80 - 279,349.20. Base pay offered may vary depending on market location, job-related knowledge, skills, and experience. The position may include a short-term incentive bonus opportunity; eligibility to participate in an equity-based long-term incentive program or retirement contribution for salaried/hourly roles. Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and health benefits (medical, prescription drug, dental, vision). Details of participation in benefit plans will be provided if an offer is made. At-will employment status and Company right to modify compensation are reserved. Date Posted:
10-Sept-2025 Closing Date:
14-Sept-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. We welcome applications from all qualified candidates, regardless of protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr