Hi, my name is Mirna. I lead the Regulatory department at Abbott Hematology. I am looking to develop the next generation of Regulatory Professionals. We have new technology with new applications that will revolutionize the Hematology field. If you are a high energy individual that likes to be at the cutting edge of technology, join us. You will have the opportunity to interact with US and worldwide Health Authority Agencies. You will have up to the minute worldwide regulatory intelligence on the ever changing regulatory environment. Lets navigate the global regulatory landscape to bring these much needed innovations to patients worldwide.
Primary Job Function
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.
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
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
Supervisory / Management Responsibilities
Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members.
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. 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 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.)
Minimum Experience / Training Required
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).
3+ years 510K submission experience
2+years Ad/Promo experience