Deputy Director of Global Regulatory Strategies—New Jersey

Deputy Director of Global Regulatory Strategies—New Jersey

January 9th, 2017 by

Tanner and Associates is recruiting a Deputy Director of Global Regulatory Strategies based out of New Jersey.

Responsibilities:

·         Planning and managing regulatory activities for regulatory projects within an assigned product area.

  • Managing regulatory submissions for U.S. and foreign regulatory bodies in support of product development programs
  • Developing and implementing regulatory plans throughout the product development lifecycle
  • Collaborating with Global project teams to ensure that all regulatory requirements are properly resourced and communicated
  • Working closely with other regulatory groups, clinical research, product development teams, and commercial groups
  • Leading interactions with regulatory authorities and regulatory filings, ie. FDA,  EU Agencies including the EMEA
  • Managing submissions and maintenance of licenses based on product and regulatory strategies
  • Providing regulatory advice regarding issues/strategies surrounding new product development and ongoing product support

Requirements:

  • MS, PhD, PharmD or MD
  • 10 or more years of pharmaceutical industry experience
  • At least 5 years experience with a proven record in regulatory affairs
  • In depth knowledge of clinical trial methodology, clinical auditing and drug safety data analysis
  • Extensive knowledge of FDA/EMEA requirements including ICH guidelines and regional requirements
  • Sound understanding of current global and regional trends in regulatory affairs as it may impact the company’s business
  • Must demonstrate strategic ability and strong leadership skills and management skills of global regulatory teams operating in a matrix environment and the coordination of global regulatory managers
  • Experience from investigational to marketing registration in major regions of the world is preferred

Please send a CV and contact information to Jake Tanner at careers@biotechsearch.com .  US candidates only please.

Thanks,

Jake Tanner

Tanner & Associates

Careers@biotechsearch.com

760.598.3363

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