Kelly Services has an opening for a
Regulatory Project Manager (RPM) in Gaithersburg, MD
for a one-year contract assignment . The 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.
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:
o Submission delivery strategy of all dossiers and all application types per market and /or region.
o Review of documents (e.g. response documents, study protocols, PSRs, etc.).
o 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
Provide coaching, mentoring and knowledge sharing within the RPM skill group.
Contribute to process improvement.
Relevant University 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
Managed regulatory deliverables at the project level
Thorough knowledge of the drug development process
Required Skills and Capabilities:
Excellent written and verbal communication skills
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
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
*perks to be received upon meeting eligibility requirements
With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.