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Abbott Regulatory Affairs Project Manager, Ad/Promo in Abbott Park, 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 103,000 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.

Position Summary

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.

Main Responsibilities

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 regulatory

management.

Assist in the development of multi country regulatory strategy and update strategy based upon regulatory

changes.

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 and

recommend 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 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.

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 patent

information.

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-associated

events • 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 to

regulatory agencies • Report adverse events to regulatory agencies and internal stakeholders.

Provide regulatory input for product recalls and recall communications.

Accountability

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.

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.

Qualifications

Bachelor's degree (or equivalent), Bachelor’s degree in science (biology, chemistry, microbiology,

immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is

preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 2-5 years of

experience in regulatory preferred but may consider quality assurance, research and

development/support, scientific affairs, operations, or related area. 4-5 years’ experience in a regulated

industry (e.g., medical products, nutritionals).

Preferred Qualifications

2+ years in Ad/Promo regulatory experience

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 corpjat@abbott.com

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