Regulatory Affairs Manger 1

Job Title: Regulatory Affairs Manager I

Introduction to role

Are you ready to lead the charge in regulatory affairs and make a significant impact in the biopharmaceutical industry? As a Regulatory Affairs Manager I, you'll be at the forefront of planning, coordinating, and implementing regulatory results. This role requires a dynamic professional who can navigate the complexities of regulatory project management for both simple and moderately complex products across various regions. You'll be a key player in shaping submission strategies, handling dossiers, and collaborating with cross-functional teams to drive business objectives. Are you prepared to take on this exciting challenge?

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 standard processes 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 direction. Capable of leading cross-functional activities. Participates in continuous improvement of process and tools/systems. Participates in global initiatives.
- Leads and/or gives 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, implements, and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated collaborators.
- 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 results, including generating work requests and submission content plans, submission tracking, TMF, and document management using 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.
- Gives to process improvement.

Essential Skills/Experience

- Relevant University Degree in Science or related team
- Minimum 5 years of regulatory experience within the biopharmaceutical industry, including license maintenance, labeling, 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
- Led regulatory results at the project level
- Experience working with people from locations outside of India, especially Europe and/or USA

When we put unexpected teams in the same room, we fuel 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 a vision to eliminate cancer as a cause of death. Our commitment to pioneering new frontiers in oncology is unwavering. With powerful science fused with the latest technology, we aim to deliver breakthroughs that transform patient outcomes. Our collaborative research environment unites academia and industry to expedite research in some of the hardest-to-treat cancers. Here, you'll have the opportunity to build a rewarding career while improving the lives of millions.

Ready to make a difference? Apply now to join our team!

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.