Abbott Regulatory Affairs Project Manager - Advertising/Promotions, IVD/Clinical Chemistry/Pharmacology in Lake Forest, Illinois
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries
Review and approve advertising and promotional items to ensure regulatory compliance. Sources may
include Digital and social media promotional materials, Sales and marketing training, customer interfacing
materials. Ensure external communications meet regulations.
Note: Responsibilities for this position don't include product submissions tied to registration of the product
with the authorities.
As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge
of scientific, regulatory and business issues to enable products that are developed, manufactured or
distributed to meet required legislation. The individual has department/group/site level influence and is
generally recognized as an expert resource within the department. The individual may share knowledge
and expertise with others in support of team activities. The individual may identify data needed, obtain
these data and ensure that they are effectively presented for the registration of products worldwide.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
• Develop new regulatory policies, processes and
SOPs and train key personnel on them.
Evaluate regulatory risks of division policies, processes, procedures.
Provide regulatory input to product lifecycle planning.
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatorymanagement.
Assist in the development of multi country regulatory strategy and update strategy based upon regulatorychanges.
Assist in regulatory due diligence for potential and new acquisitions.
Utilize technical regulatory skills to propose strategies on complex issues.
Determine submission and approval requirements.
Identify emerging issues.
Monitor trade association positions for impact on company products.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop
solutions with other members of regulatory and related teams.
Recruit, develop and mentor regulatory professionals.
Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases andrecommend solutions.
Compile, prepare, review and submit regulatory submission to authorities.
Monitor impact of changing regulations on submission strategies and update internal stakeholders.
Monitor applications under regulatory review.
Communicate application progress to internal stakeholders.
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatoryauthorities.
Evaluate proposed pre-clinical, clinical and manufacturing changes for regulatory filing strategies.
Negotiate and interact with regulatory authorities during the development and review process to ensuresubmission approval.
Provide strategic input and technical guidance on regulatory requirements to development teams.
Manage and execute preapproval compliance activities.
Oversee processes involved with maintaining annual licenses, registrations, listings and patentinformation.
Ensure compliance with product post marketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance.
Ensure external communications meet regulations.
Develop, implement and manage appropriate SOPs and systems to track and manage product-associatedevents
Actively contribute to the development and functioning of the crisis/issue management program.
Oversee system to ensure that product safety issues and product-associated events are reported toregulatory agencies
Report adverse events to regulatory agencies and internal stakeholders.
Provide regulatory input for product recalls and recall communications.
Individuals execute and manage technical and scientific regulatory activities.
Must function independently as a decision-maker on regulatory issues, and must assure that deadlines aremet.
Effectively communicate, prepare, and negotiate both internally and externally with various regulatoryagencies.
Properly interpret and apply regulatory requirements.
Work is performed without appreciable direction and exercises some latitude in determining technicalobjectives of assignments.
Completed work is reviewed from a relatively long- term perspective for desired results.
Individual is recognized as a discipline expert and resource in regulatory affairs.
Bachelor's Degree (or equivalent).
Bachelor’s Degree in science (biology, chemistry, microbiology,immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields ispreferred.
M.S. in a technical area or M.B.A. is preferred.
Ph.D. in a technical area or law is helpful.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Experience in regulatory preferred but may consider quality assurance, research and 2-5 years of development/support, scientific affairs, operations, or related area.
4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 2(+) years in Ad/Promo (Advertising / Promotions) regulatory experience with any of the following medical products : IVD 's, Clinical Chemistry and/or Pharmacology
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com