The Specialist, Regulatory Affairs Management (RAM) will support the strategic development and execution of regulatory activities for assigned products and regulatory jurisdictions with a goal of achieving registrational approval from governmental authorities and post approval life cycle management.
The successful candidate will:
Provide operational and strategic regulatory input to cross-functional teams responsible for executing programs in relevant regulatory jurisdictions
Ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities
Provide ad hoc support to cross functional teams or internal Regulatory Affairs department, where necessary
Primary Responsibilities:
Support members of the Regulatory Sub Team (RST) to deliver business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.)
Oversee the coordination and execution of operational activities to ensure program deliverables are submitted on time
Support and contribute to internal governance, advisory or other relevant internal activities, to assist with the development and management of select Regulatory processes and procedures, as well as inspection/audit support
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
Proactively stay abreast of the latest regulatory requirements and trends, and ensure information is shared with members of Regulatory Affairs department to assist with the shaping of the regulatory science environment
Qualifications
Bachelor's degree in a scientific or regulatory affairs with at least 5 years relevant experience
An understanding of regulatory processes and regulations, across all stages of drug development (preapproval, authorization and post marketing)
Ability to manage multiple stakeholders and build team relationships to collaborate in a global team environment at all levels of the organization
Experience managing regulatory activities for the global development of products through all stages of development including pre-approval and marketed assets
Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organization
Excellent written and verbal communication skills
A proven track record of leadership and project management in regulatory affairs is required
Strong strategic and technical regulatory knowledge, with long-term and global vision
Understanding of GxPs in relevant areas and solid understanding of where to seek and how to interpret regulatory information
The duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
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.
