Abbott Sr Specialist Regulatory Affairs in Santa Clara, California
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 Job Function:
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
· Assist in SOP development and review
· Provide regulatory input to product lifecycle planning
· Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
· Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
· Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
· Determine trade issues to anticipate regulatory obstacles
· Determine and communicate submission and approval requirements
· Participate in risk-benefit analysis for regulatory compliance
· Assess the acceptability of quality, preclinical and clinical documentation for submission filing
· Compile, prepare, review and submit regulatory submission to authorities
· Monitor impact of changing regulations on submission strategies
· Monitor applications under regulatory review
· Monitor and submit applicable reports to regulatory authorities
· Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
· Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
· Maintain annual licenses, registrations, listings and patent information
· Assist compliance with product postmarketing approval requirements
· Review and approve advertising and promotional items to ensure regulatory compliance
· Assess external communications relative to regulations
· Review regulatory aspects of contracts
· Assist with label development and review for compliance before release
· Submit and review change controls to determine the level of change and consequent submission requirements
· Analyze the input of cumulative product changes to current product submissions
· Contribute to the development and functioning of the crisis/ issue management program
· Ensure product safety issues and product-associated events are reported to regulatory agencies
· Provide regulatory input for product recalls and recall communications
Job specific responsibilities may include (chooses applicable areas and expands as appropriate);
· Medical writing
· Advertising and promotion
· Controlled substances (e.g. DEA)
· Restricted substances (e.g. REACH)
· Compendial / standards
· Import / export
· Country specific regulatory support
Position Accountability / Scope:
Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Work is reviewed upon completion for adequacy in meeting objectives. Individual is recognized as an expert in work group.
· Understands business environment and relates extensive knowledge of internal and external activities to trends.
· Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
· Participates in the development of others by facilitating training and providing feedback and guidance.
· May lead a cross-functional project team.
· Provides technical leadership to business units.
· Acts as a mentor to less-experienced staff.
· Exercises judgment independently.
· Plans and organizes project assignments of substantial variety and complexity.
· Initiates or maintains schedule for projects and project milestones.
· Establishes priorities of individual or project assignments.
· Selects methods and techniques to lead a project to completion.
· Erroneous decisions or recommendations would typically result in failure to achieve organizational objective.
Preferred: US/Canada experience
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Note: Higher education may compensate for years of experience.
United States > Santa Clara : Building B - SC Floor-2
Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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