Regulatory Affairs - Pharmacy

At VEBT, employees are our No. 1 investment. We are looking for a high functioning, detail-oriented professional who can juggle various tasks with accuracy and is interested in molding their logistics career with an award-winning, growing company.

Duties and Responsibilities:

• Provides expert medical/scientific advice and guidance to support the needs of internal partners for designated therapeutic area
• Continually seeks to increase market awareness and expertise by developing relationships with outside organizations/experts to support research programs, clinical development programs, licensed product maintenance and optimization and life cycle management.
• Possesses deep therapeutic area/scientific knowledge and in-depth knowledge of medical affairs and clinical development.
• Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific objectives and business objectives of the Therapeutic Area Section.
• Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.
  
• Prepare periodic reports for company's executives and top managers
• Provide expertise for Audit and Compliance activities to the company and its clients.

Qualifications

• Minimum (3) three years’ related experience in compliance, privacy and/or regulatory affairs, legal assistant/paralegal
• Minimum of a BS degree in Pharmacy, Chemistry, Biology or Microbiology
• Minimum 5 years regulatory experience preferred and/or pharmaceutical industry experience
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational and interpersonal skills.

This is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.