At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Primary Function/Primary Goals/Objectives:
Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
Execute regulatory tasks and play a consultative role by partnering across business functions.
Assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.
Prepare and submit documentation or oversee preparation of documentation needed for registration worldwide.
Provide technical leadership to business units.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs.
Assist in Regulatory SOP development and review.
Provide regulatory input to product lifecycle planning.
Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
Interpret and apply regulatory requirements.
Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
Understand the business environment and relate extensive knowledge of internal and external activities to trends; Determine trade issues to anticipate regulatory obstacles. Participate in risk-benefit analysis for regulatory compliance.
Plan and organize project assignments of substantial variety and complexity; initiate and/or maintain schedule for projects and project milestones.
Maintain regulatory data in electronic systems.
Depending on specific role, the Sr Regulatory Affairs Specialist may be involved in various regulatory activities (review of clinical documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval of label changes, advertising and promotional items; provide regulatory input to product safety issues and product recalls, etc.)
May provide direction and guidance to exempt and/or skilled non-exempt levels of employees; act as a mentor to less-experienced staff.
May be asked to evaluate performance of others and to assist in career development planning.
Participate in the development of others by facilitating training and providing feedback and guidance.
Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
Perform work without appreciable direction.
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