Regulatory Affairs Manager I

Job Title: Regulatory Affairs Manager I

Career Level - D

Introduction to role

Are you ready to make a difference in the world of regulatory affairs? As a Regulatory Affairs Manager I, you will lead the end-to-end planning, coordination, and execution of assigned deliverables. You will work flexibly within the team, taking on various roles as needed. Your expertise will be crucial in applying established standards to manage regulatory projects for simple to moderately complex products and regions with minimal supervision.

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 in 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 highlights 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 organization.
- 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 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

- Regulatory affairs experience across a broad range of markets
- Managed regulatory deliverables at the project level
- Experience working with people from locations outside of India, especially Europe and/or USA
- 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 bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We thrive in an inclusive, diverse environment where we draw on our collective knowledge to take smart risks and uncover new ways to deliver better outcomes for patients.

Ready to make a difference? Apply now!