Tanner and Associates is recruiting a Deputy Director of Global Regulatory Strategies based out of New Jersey.
· 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
- 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 email@example.com . US candidates only please.
Tanner & Associates