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Kelly Services Project Manager - Regulatory Affairs in Madison, New Jersey

Project Manager II – Regulatory Affairs

What's next for you? This great job. Kelly is looking for a dynamic Project Manager II for our top biomedical client in Madison, NJ. The ideal candidate will have 5 Years of Regulatory Affairs Experience in annual reporting process and requirements. Labeling and Marketed Products experience preferred. This is a one-year assignment with possibility of extension.

* MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) NO C2C, 1099, etc. **

  • Shift: 8:00am to 5:00pm

  • Location: Possibly 1-2 days remote but three days / week is required to be onsite

  • Pay: Commiserate with experience and education

Summary: Under general direction, responsible for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps Company informed of significant regulatory issues that affect assigned products/projects.

In this role you will:

  • Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

  • Directs, coordinates and prioritizes the daily activities of assigned products

  • Prepares, reviews and approves regulatory submissions (i.e. NDAs, amendments, annual report, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s.

  • Interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.

  • Review and approve change labeling and core safety document changes

  • Implements policies to assure on-going compliance of Regulatory Affairs activities.

  • Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.

  • Interacts with the FDA to facilitate approval of the regulatory submissions.

  • Maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.

  • Meets project deadlines and established performance standards.

  • Complies with all Company policies and procedures, including safety rules and regulations, and guides subordinates in this area.

  • Performs related duties as assigned and any required updates to trackers or routine reports as applicable

Requirements:

  • Regulatory Strategy

  • Bachelor’s degree required

  • 5 Years of Regulatory Affairs Experience at minimum,

  • NDA/IND/ANDA/PADER/PSUR Annual Reports

  • FDA interaction Experience

  • Ability to work in a GRPT or project team

  • Understand the basic Regulations for Registration/Postmarketing/Labeling activities

  • Labeling and Marketed Products experience preferred

  • FDA, ICH, SOP and cGMP standards, guidelines and regulatory compliance regulations.

  • Annual reporting process and requirements for routine submissions and Pertinent Federal and State laws related to pharmaceutical regulatory affairs.

  • Supervision and training practices and methods.

  • Principles and practices of budget preparation and administration.

  • Strong Logic

  • Computer Skills

  • Ability to prioritize

  • Excellent Communication skills

Skill in:

  • Creating, planning and implementing group goals, objectives and practices for effective, efficient and cost-effective management of allocated resources.

  • Responding to general and/or sensitive inquiries from management, employees and regulatory agencies.

  • Communicating clearly and concisely, both orally and in writing.

  • Managing multiple projects, duties and assignments.

  • Interpreting and applying Federal, state and local policies, procedures, laws and regulations.

  • Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.

  • Establishing and maintaining cooperative working relationships with others.

  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

Why Kelly?

As a Kelly employee, you’ll have access to world-class perks, including:

  • Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

  • *Group insurance options

  • Service bonus plan

  • Holiday pay plan

  • Weekly electronic pay options

  • Online training campus that provides more than 3,000 free courses to help improve and develop skills

  • Exclusive online employee community

  • Employee assistance program available at no cost

  • Corporate discounts

  • Transportation Spending Accounts

*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.

Apply Today!

*Important information: This position is recruited by a remote, national, Kelly office, NOT your local Kelly branch. Applicant must have a legal right to work in the US without sponsorship or VISA transfer for this position. There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® ?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 (plus, did we mention we provide a ton of benefits ?). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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