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Global Regulatory Manager

  • Location: Lawrenceville, Mercer, New Jersey
  • Job Type:Contract

Posted 9 days ago

  • Expiry Date: 20 August 2021

Job Description:

Responsibilities:

  • Responsible for driving regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of Bclient MS products.

  • Responsible for interactions with Country Regulatory managers/regional leads regarding product registrations.

  • Drives and support local projects and department related assignments.

  • Responsible to keep up to date with the regulatory environment within the industry.

  • Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases and manage all updates in our RIM Veeva vault system

  • Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.

  • Responsible for overall regulatory related topics for assigned products /therapeutic area.

  • Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time

  • Manage, track, review regulatory deliverables from external partners in line with vendor manager

Required:

  • Doctor of Pharmacy or equivalent

  • 2-4 years of relevant experience expected , especially in Intercontinental region

  • Demonstrated ability to break down complex, scientific content into logical components.

  • Ability to write in a clear, concise, and persuasive manner

  • Strong project management skills

  • Highly proficient in the use of Microsoft WORD and POWERPOINT

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.