Director, Regulatory Affairs, Nutritional RA Team

Regulatory Affairs/Clinical Affairs Charlottesville, Virgina


Description

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Responsible for the strategic leadership of staff who are responsible for the hands-on regulatory activities associated with bringing new Nutritional and Dietary Supplement products to market and commercial product maintenance for a variety of domestic and/or international regulated products.  Product categories currently include Infant Formula, Liquid Nutritional, and Dietary Supplement products.

MAJOR RESPONSIBILITIES

  • Confirms that project plan due dates are consistent with regulatory strategy
  • Work directly with Regulatory Agencies to resolve regulatory issues
  • Direct and manage contacts with outside consultants to resolve regulatory issues.
  • Represent regulatory affairs in leadership and executive meetings.
  • Ensure appropriate basis to marketing strategies are identified and/or implemented; Identifies and employs advanced regulatory strategies.
  • Communicate and collaborate with senior and executive management in all areas of the company
  • Support and lead a continuous improvement environment
  • Provide oversight for RA processes and systems.
  • Hire, train and evaluate performance of direct reports.
  • Manage and prioritize department resources.
  • Projects as assigned by business unit leader and executives
  • Provide strategic regulatory guidance to Marketing and Business Development in developing growth strategies to enter new business segments, product categories, technology and inorganic acquisitions     
  • Work directly with FDA, trade associations and outside regulatory and legal experts to influence emerging legislation, regulations, guidances and FDA decision making on matters material to Perrigo
  • Develop strategies and tactics to support first to market commercial opportunities and minimize time to product launch.
  • Recruit new leadership talent and mentor staff to maximize the leadership talent pool.

KNOWLEDGE AND EXPERIENCE

  • Must demonstrate advanced analytical skills, the ability to identify and apply policies and general regulations to specific products or projects and create new policies as required.
  • Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for executive stakeholders inside and outside of Regulatory Affairs.
  • Advanced verbal and written presentation and communication skills are necessary.
  • Ability to utilize business and financial acumen in decision making
  • The ability to effectively lead management teams is required.
  • Advanced knowledge of scientific, regulatory, and legal terminology is necessary.
  • These skills are normally acquired through possession of a bachelor degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined with 8-10 years of experience in the health care or pharmaceutical industry and 10+ years of hands on experience in regulatory affairs.
  • 7+ or more years of experience in direct supervision.
  • Advanced degree preferred.

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.

Due to the highly regulated pharmaceutical industry and legal requirements, you may be subject to post employment background checks.