• United States Of America, Usa

Job Description:

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 peoples exceptional skills with those of people from all over the globe

As a Regulatory Project Managerin Gaithersburg, MD, youll 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

AstraZenecas 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

Position Description
The Regulatory Project Manager (RPM) 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

Position 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 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 (eg response 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 simple and with experience, increasingly more complex submissions throughout the products life cycle from either a global and/or regional perspective
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 propose mitigations to Lead RPM and cross functional teams
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
Provide coaching, mentoring and knowledge sharing within the RPM skill group
Contribute to process improvement

Minimum Requirements Education and Experience

Relevant BS/BA Degree in Science or related discipline
1-3 years of 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

Preferred Experience

Regulatory experience
Managed regulatory deliverables at the project level
Thorough knowledge of the drug development process
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 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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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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