27 days old

Regulatory Affairs Manager

Kelly Services
Horsham, PA 19044
**Seeking a Regulatory Affairs Manager for a 12 month assignment in either Raritan or Titusville, NJ or Horsham, PA.**

The RPM will provide business support to GRA. Assists GRTs in determining resource requirements utilizing scheduling and resource management tools to support late development teams without dedicated RPMs in R&D. Creates project and portfolio level reports utilizing various systems to support decision making. Will manage the regulatory end-to-end process from entry into late development through launch. Will represent Regulatory Program Management at the GRT. Translates regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input. Works out regulatory scenarios to support decision making in line with Regulatory and CDT strategy. Supports early risk identification and development of mitigation strategies. Works in close collaboration with the Regulatory Leader (GRL) to proactively prepare regulatory activities to be discussed in the GRT. Works in close collaboration with the Regulatory Liaisons and Professionals to work out NA-EMEA-APJLA specific details on Health Authority interactions and submissions. Works in close collaboration with Submission Operations at timings of pre-submission activities. Is single Point of Contact for Regulatory Program Management activities. ?

Provides cross-functional leadership to the submission teams in executing the finalized pre-submission plan, including direct management of Modules 1 and 2. Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA EMEA - APJLA): Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions ....) Monitors regulatory driven key milestones, decision points and critical path activities. Creates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short- and long-term deliverables; informs stakeholders on project deliverables status. Coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs). Owns the Global Regulatory Affairs (GRA) schedule in V6; creation, monitoring and maintenance. Represents Regulatory Program Management at the PMT. Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the regulatory strategy with the CDT strategy. Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the regulatory strategy. Proactively manages the regulatory development plan (scope, time, cost). Is single Point of Contact for Regulatory Program Management Activities.


B.S. or advanced degree in pharmaceutical-related subject. Professional project management certification is a plus. Five years of relevant experience including at least 3-5 years in (bio)pharmaceutical R&D. Experience in regulatory matrix organization is preferred. Project management experience in R&D drug development is a must. Detailed knowledge of project planning, tracking, resource management, project planning and scheduling tools, and cross-project analyses. Registration experience with global submissions or preparation of dossiers is preferred. Understanding of Regulatory processes, both pre- and post-marketing. Knowledge of regulations, guidelines and regulatory requirements is preferred. Critical Competencies, Change Leadership, Interdependent Partnering, Innovation, Results Driven, Project Team Management and Development.


Location: Raritan, NJ; Titusville, NJ or Springhouse, PA.


**For immediate consideration, please send your resume in a WORD document to**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-05-08 Expires: 2020-06-08

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Regulatory Affairs Manager

Kelly Services
Horsham, PA 19044

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