- Bachelor's degree (or equivalent) is required - preferred area of focus in science (biology, chemistry, nutrition, dietetics, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields. M.S. in a technical area or M.B.A. is preferred.
- A Ph.D. in a technical area or law is preferred.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 2-3 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area. 3-4 years of experience in a regulated industry (e.g., nutritionals, medical products).
- Note: Higher education may compensate for years of experience or vice versa.
Regulatory knowledge of (as applicable):
- Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.
- GxPs (GMPs, GLPs, GCPs).
- Principles and requirements of promotion, advertising and labeling.
- Communication skills and ability to:
- Communicate effectively verbally and in writing.
- Communicate with diverse audiences and personnel.
- Work with and negotiate with people from various disciplines, organizations, and cultures.
- Follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy.
- Evaluate various technical alternatives.
- Strong attention to detail.
- Create and manage project plans and timelines.
- Think analytically; organize and track complex information.
- Proficient computer skills.
- Execute and manage technical and scientific regulatory activities. Function independently as a decision-maker on regulatory issues and assure that deadlines are met. Effectively communicate, prepare, and negotiate internally and externally with various regulatory agencies.
- May lead a cross-functional project team.
AN Abbott Nutrition
United States > Abbott Park : AP06C Floor-6
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf