• United States Of America, Usa
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  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges We do this with the utmost 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 an Associate Regulatory Project Director in Gaithersburg, MD , youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives

Description

The Associate Regulatory Project Director (ARPD) 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 ARPD provides regulatory expertise and guidance on procedural and documentation requirementsto 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 (eg, 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 products life cycle from either a global and/or regional perspective
Lead GRST & GRET sub-teams, ie 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
Allocate RPM 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
When assigned Market Contact role ARPD, responsibilities to include
Develop, maintain and provide RPM with clear, concise, timely guidance on current priorities and regulatory requirements for assigned market/region(s) to support RPM project deliverables and business tactical/strategic decision-making
Drive market/region knowledge sharing with key stakeholders (eg Marketing Companies, Regulatory Science & Strategy, CMC Regulatory Compliance) through appropriate meetings, networking and communications
Provide support across RPM to maintain and continuously improve regulatory consistency and to achieve right first time submissions in assigned market/region(s)
Proactively develop close relationships and have appropriate levels of interactive communication with Marketing Company staff for assigned market/region(s) to drive effective 2-way sharing of information and interpretation of regulatory requirements relating to RPM deliverables
Coordinate gathering of documentation to support tenders
Oversee general Regulatory compliance in assigned markets/regions and escalate any compliance issues

Minimum Requirements Education and Experience

BS/MS Degree in Science or related discipline
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

Skills and Capabilities

Excellent written and verbal communication skills
Cultural awareness
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Proficiency with common project management (eg, 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

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 : 09th Jun 2020

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