Regulatory Affairs Manager I

Job Title: Regulatory Affairs Manager I

Global Career Level: D

Introduction to role:

Are you ready to make a difference in the world of regulatory affairs?

The Regulatory Affairs Manager I is a regulatory affairs professional with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor. The Regulatory Affairs Manager I may take on the accountabilities for a number of different roles within the team. The Regulatory Affairs Manager I is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the lead

The Regulatory Affairs Manager I is fully proficient in applying established standards to perform regulatory project management for simple/moderately complex products/regions and under minimal supervision.

Regulatory Project Management

Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory Execution Team (GRET), Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Dossier Management

Plans and manages Regulatory and basic Clinical and Non-Clinical publishing deliverables, as well as associated lifecycle and license information. Collaborates with publishing teams to assure efficient delivery of end to end submission output to project timelines.

Accountabilities:

Regulatory Project Management

• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.

• Provides 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. regulatory maintenance documents, response documents, etc.).

• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

• Uses and shares 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.

• Fully proficient in applying established standards. Performs regulatory project management for simple reports / regions under minimal supervision. Capable of leading cross functional activities. Participates continuous improvement of process and tools/systems. Participates in global initiatives

• Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.

• Liaises closely with cross-functional members with aligned product responsibilities.

• Develops, executes and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated stakeholders.

• Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RAM and line manager.

• Identifies regulatory risks and proposes mitigations to the lead and cross functional teams.

• Supports operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.

• Provides coaching, mentoring and knowledge sharing within the regulatory organisation.

• Contributes to process improvement.

Essential Skills/Experience:

• Relevant University Degree in Science or related discipline

• Minimum 5 years of regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in regulated markets General knowledge of drug development

• Thorough knowledge of the regulatory product maintenance process

• Strong project management skills

• Leadership skills, including experience leading multi-disciplinary project teams

Desirable Skills/Experience:

Preferred Experience

• Regulatory affairs experience across a broad range of markets

• Managed regulatory deliverables at the project level

• Experience of working with people from locations outside of India, especially Europe and/or USA

Skills and Capabilities

• Excellent English 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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by science and success, transforming breakthrough innovations into tangible solutions for patients worldwide. Our inclusive environment fosters collaboration across global teams, enabling us to share best practices and unlock regulatory knowledge. With a rich pipeline offering exposure to diverse therapy areas, you'll have the opportunity to take on new challenges and drive change in drug development strategies.

Ready to make an impact? Apply now and be part of our journey to bring life-changing medicines to patients around the globe!

Date Posted

Closing Date

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.