Deputy Director of Global Regulatory Strategies—New Jersey

January 5th, 2018 by admin

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

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@www.biotechsearch.com . US candidates only please.

Thanks,

Jake Tanner

Tanner & Associates

760.598.3363

Category : biotech-pharma-openings