Director, Regulatory Affairs, Nutritional RA Team
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.
- 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.