The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
• Submission delivery strategy of all dossiers and all application types per market and /or region.
• Review of documents (e.g. response documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share guidelines, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product's life cycle from either a global and/or regional perspective.
• Develop, complete and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.
• Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement.
• Use available AI tools effectively and responsibly to improve efficiency, streamline routine activities and support high quality regulatory deliverables.

Minimum Requirements -Education and Experience

• Relevant University Degree in Science or related discipline
• 2-4 years of experience in Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Regulatory experience
• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Knowledge of AZ Business and processes

Skills and Capabilities

• Excellent written and verbal communication skills
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

• Global Regulatory Leads (GRLs)
• Regional Leads (eg, US, EU international RADs)
• Lead RPM
• Regulatory skill groups in ORSS, Late R&I and Late CVRM
• Other R&D functions
• Marketing Companies
• Health Authorities
• External collaboration partners

Reporting Relationship

• Direct Reports - None
• Indirect Reports -None

Annual base salary for this position ranges from 107,196.80 to 140,695.80.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.