Associate Regulatory Affairs Director

AstraZeneca•Gaithersburg, MD

3d•Hybrid

About The Position

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to Role: The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD 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.

Requirements

Relevant University Degree in Science or related field
3 years of experience
Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
Thorough Knowledge of drug development
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams
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 partner management skills
Ability to analyze problems and recommend actions
Continuous Improvement and knowledge sharing focused

Nice To Haves

Managed first wave Marketing Application and/or LCM submissions
Managed complex regulatory deliverables across projects/products
Knowledge of AZ Business and processes

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 expertise 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 documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.) Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
Use and share best practices, 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 both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
Lead GRST & GRET sub-teams, i.e. Cross functional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
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 communicate mitigations to Lead RPM and cross functional teams.
Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
Provide coaching, mentoring and knowledge sharing within the RAM skill group.
Contribute to process improvement.
Lead the GRET (Global Regulatory Execution Team).
Overall accountability for the project management of all GRET results.
Key member of the Global Regulatory Strategy Team (GRST) with focus to deliver the GRST product plan submission breakthroughs. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members.
Identify regulatory risks and risk mitigation strategies for GRET executions and results (with input from all team members).
Drive the GRST and GRET resourcing process.
Supports Fee forecasting activities.
Allocate RAM resources to the GRET deliverables.
Liaise with GPM and other functional project managers.
Knowledge sharing and RAM development; the go-to person for RAM project guidance and support, provides and facilitates coaching within/between the GRET and GRST.
Develop, maintain and provide RAM with clear, concise, timely guidance on current priorities and regulatory requirements for assigned market/region(s) to support RAM project deliverables and business tactical/strategic decision-making.
Drive market/region knowledge sharing with key participants (e.g., Marketing Companies, Regulatory Skill Groups, CMC Regulatory Compliance) through appropriate meetings, networking and communications.
Provide support across RAM to maintain and continuously improve regulatory consistency and to achieve right first time submissions in assigned market/region(s).
Proactively develop close relationships and have appropriate levels of interactive communication with Marketing Company staff for assigned market/region(s) to drive effective 2-way sharing of information and interpretation of regulatory requirements relating to RAM deliverables.
Coordinate gathering of documentation to support tenders.
Oversee general Regulatory compliance in assigned markets/regions and advance any