Associate Regulatory Affairs Director

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 an Associate Regulatory Affairs Director in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

Description:

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD 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.

Accountabilities/Responsibilities:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory expertise 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 documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• 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.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Lead GRST & GRET sub-teams, i.e. Crossfunctional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• 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.
• Identify regulatory risks and communicate mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring and knowledge sharing within the RPM skill group.
• Contribute to process improvement.
• When assigned Lead RPM role ARPD, responsibilities to include:
• Lead the GRET (Global Regulatory Execution Team).
• Overall accountability for the project management of all GRET deliverables.
• Key member of the Global Regulatory Strategy Team (GRST) with focus to deliver the GRST product plan submission milestones. This is achieved by development and execution of operationally efficient submission delivery plans by GRST and GRET members.
• Identify regulatory risks and risk mitigation strategies for GRET executions and deliverables (with input from all team members).
• Drive the GRST and GRET resourcing process.
• Supports Fee forecasting activities.
• AllocateRPM resources to the GRET deliverables.
• Liaise with GPM and other functional project managers.
• Knowledge sharing and RPM development; the go-to person for RPM project guidance and support, provides and facilitates coaching within/between the GRET and GRST.

Minimum Requirements -Education and Experience

• Bachelor Degree and 3+ years experience or Masters Degree and 1+ years experience
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
• Thorough Knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Managed first wave Marketing Application and/or LCM submissions
• Managed complex regulatory deliverables across projects/products
• Knowledge of AZ Business and processes

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.

The annual base salary for this position ranges from $135,182.40 - 202,773.60 USD Annual

However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.