This is what you will do:
The Associate Regulatory Affairs Director (ARAD), Regulatory Science & Execution will be responsible for supporting strategies and executing regulatory activities for assigned product and regulatory jurisdictions, 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 operational and strategic regulatory input to cross-functional teams responsible for executing programs in relevant regulatory jurisdictions. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
Job Duties and Responsibilities
- Responsible for the regulatory execution and implementation of regulatory strategies in the relevant regulatory jurisdiction, actively supporting relevant Regulatory Leads via the Regulatory Subteam (RSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.).
- Actively contributes to 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.
- Responsible to oversee operational activities and execution related to the Regulatory management in the relevant jurisdiction, in support of the Regulatory Lead, coordinating teams working on such deliverables.
- Supports the relevant Regulatory Lead and contributes actively to internal Governance and advisory bodies, or other relevant internal activities, including on the development and management of select Regulatory processes and procedures, as well as inspection/audit support.
- 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 Enterprise, with Health Authorities and other external stakeholders.
You will need to have:
Essential Qualifications.
Qualifications
- 6+ years of Regulatory experience in the pharmaceutical industry.
- Strong knowledge of drug development and regulatory policy, couple by excellent scientific and business judgment.
- Experience managing regulatory activities in at least one [several] regulatory jurisdiction (e.g. EU, US, China, Japan) for the global development of products through all stages of development including pre-approval and marketed 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.
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
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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