Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.

Job Title

• Medical Director, Clinical

Position Description

• Associate Director, Regulatory Affairs

Position Responsibilities

• Direct management of assigned programs
• Driving all submission activities (IND/CTA, trial maintenance, NDA/BLA) and health authority interactions (meeting requests and briefing documents)
• Represent Regulatory Affairs at various project team and working group meetings
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
• Contribute significantly to the development of regulatory strategy plans
• Liaise with partnering companies to ensure regulatory alliance
• Act as direct point of contact with FDA and other regulatory authorities for general issues
• Mentor and coach junior regulatory staff and other team members.
  

Position Requirements

• A minimum 4-year degree in a scientific or technical discipline; advanced degree preferred. Must have a minimum of 8 years experience in Regulatory Affairs.
• Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required. 
• Management experience is a plus. 
• Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements.
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance