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Regulatory Project Manager, Late RIA Regulatory Affairs

Location Gaithersburg, Maryland, United States Job ID R-071671 Date posted 01/24/2020

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Regulatory Project Manager in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Biopharmaceuticals R&D drives development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

AstraZeneca holds a unique position in Respiratory Disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development by leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis

Main Duties and Responsibilities

The Regulatory Project Manager (RPM), Late RIA Regulatory Affairs is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM 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.

In this role you will be responsible for understanding the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. You will 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.), and analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

You will 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.  In addition, you will be leading 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.  You will develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.  You will coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.  You will Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams. You will also support 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 GRO, MCs, CROs and/or alliance partners where relevant.  You will provide coaching, mentoring and knowledge sharing within the RPM skill group, and contribute to process improvement.

Essential Requirements

•B.A. or B.S. Degree in Science or related discipline
•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
•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

Desirable Requirements

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

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

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 authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.