VP of Regulatory Affairs - Core Logic, Inc.

Position Description

Job Title: VP, Regulatory Affairs
Location: Central CA

Description:

Main Purpose of Position:

The VP Regulatory Affairs sets the regulatory strategy for all of the company’s development programs in the US and worldwide. The VP Regulatory Affairs will have overall responsibility for the areas of Regulatory Affairs and as such will represent the company in all of their interactions with Health Regulatory Authorities in the US and worldwide.

Main Duties and Responsibilities:

• Responsible for developing and implementing the regulatory planning strategy for each product, as well as provide extensive strategic planning for regulatory issues related to drug development at all stages, including pivotal study design, to secure licensure.
• Serves as company’s tentative with FDA and/or other Agencies and will be responsible for strategic planning; development, preparation, and review of Chemistry, Manufacturing, and Controls (CMC) sections and related regulatory agency interactions.
• Overall responsibility for preparation and management of marketing authorization applications (MAAs) and new drug applications (NDAs) and their maintenance.

• Judgment, attention to detail, and desire to work independently that signifies successful teams.
• Excellent contacts with key staff within US and/or European Health Regulatory Authorities.
• Strong strategic/analytical skills to map out optimal pathways to regulatory approvals for the company’s compound candidates.
• Ability to anticipate regulatory hurdles, health authorities concerns or changes in the regulatory environment.
• Operating skills heading Regulatory Department in pharmaceutical company.
• Strong oral and written communication skills.
• Ability to set goals, build accountability and to follow-through.
• Proactive, energetic, flexible, hardworking and focused.
• Promotes positive work environment and sets highest standards for business ethics and integrity.
Working Conditions:
• 100% of work is performed in a typical office environment.
• No or very limited exposure to physical risk.
• Light physical effort – some standing and walking.
• Ability to travel both in and out of the United States.

This company’s compensation package includes a competitive salary, stock options, comprehensive benefits package, along with a dynamic corporate culture and supportive team environment.

How to Apply

Application Instructions / Send a Resume