Senior Manager, Regulatory Project Management

Senior Manager, Regulatory Project Management

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 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.

 The Senior Manager, Regulatory Project Manager (RPM) is the RPM Lead for identified projects and can be assigned to a Regulatory Sub Team (RST) to project manage RST activities. When assigned to an RST, the Senior Manager, RPM is the operational strategic partner of the Global Regulatory Lead (GRL),  the RPM RST Roles and Responsibilities (R&R) are outlined in the RST Playbook. When assigned to a major project the RPM Lead coordinates Submission Sub Team (SST) meetings and develops timelines to support regulatory filings. Creates and maintains the Submission Project Plan and Content Plan through cross functional project team discussions and, prepares timeline visuals highlighting the critical path to submission. The Senior Manager, RPM also supports the development and maintenance of RPM processes and tools

You will be responsible for:

• As RPM Lead for identified projects, you will be responsible for:

• Developing Timelines for preparation and submission of Global Regulatory Filings including initial INDs, responses to questions (RtQs), Briefing Packages, BLAs/ NDAs/ MAAs and maintenance submissions;
• Creating and maintaining Submission Project Plans, Content Plans and Responsibility Matrices through cross functional discussions;
• Proactively monitoring timelines for key program activities and tracking submission deliverables to maintain target submission dates;
• Preparing the Regulatory Submission Timelines and Visual Overview, highlighting documents on a Critical Path;
• Coordinating Submission Subteam (SST) meetings in conjunction with the GRL and Submission Leads, to discuss and align on activities, timelines, progress and resolution of issues;
• Identifying potential issues that could impact the target submission date and lead cross functional discussions to reach consensus around a solution;
• Providing a weekly/ monthly outlook on upcoming submission activities to Project Teams (deliverables and review timelines);
• Oversight of Content Planning process;

• Coordinating submission documents through the review cycles;
• Managing overall completeness of the Content Plans I the applicable information management systems;
• Coordinating with the Regulatory Operations (RegOps~) Lead on submission timelines and document status.
• Coordinating requests from Health Authorities to ensure timely responses while keeping collaborators informed.
• Acting as the Point of Contact for Strategy, Program and Portfolio Management (SPPM) to ensure Regulatory Information in PLANIT is up to date and aligned within RA;
• Providing RPM support to the RST aligned to RPMs R&R outlined in the RST Playbook;
• Supporting improvement activities for the regulatory submission process and establishing repeatable processes by applying key technologies, tools, and methods;
• Supporting the RPM team in setting standards to ensure alignment across programs;
• Supporting the development of Project Management tools to be used by the wider GRA organization;
• Supporting any other assigned RPM activities as directed by the head of RPM

Essential Qualifications:

• A minimum of 5 years pharmaceutical or other related industry experience with 3+ years of direct Regulatory Project Management (project management) experience;
• Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams;
• Good understanding of submission deliverable dependencies and ability to reflect this in project plans in order to create and maintain detailed submission schedules (as MS-Project tasks), knowledge of One Pager Pro and/ or Office Timeline Pro is a plus;
• In-depth understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission to ensure that submission goals are met in a timely manner and to the highest quality;
• The ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines;
• The ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities;
• The ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines;
• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Qualifications.

• Demonstrated Ability to manage ambiguity;
• Strong Knowledge of applicable Regulatory Agency regulations, guidelines and/or specifications (e.g. FDA, EMA, ICH etc.);
• Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, BLA, NDA, MAA and CTA etc.);
• Good experience and familiarity with Regulatory Information Management, and content/ document management tools;
• Knowledge of Starting Point templates or similar;
• Great Interest and ability for training and mentoring younger members of the RPM Team.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.