Manager Regulatory Affairs

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

What you’ll work on

• Develop new regulatory policies, processes and SOPs and train key personnel on them. 
• Evaluate regulatory risks of division policies, processes, procedures.
• Recruit, develop and manage regulatory professionals.
• Provide regulatory input to product lifecycle planning.
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
• Provide strategic input and technical guidance on regulatory requirements to development teams.
• Assist in regulatory intelligence and apply it to regulatory activities.
• Assist on US premarket activities for new product introductions.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Determine submission and approval requirements.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
• Monitor impact of changing regulations on submission strategies and update 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.
• Ensure compliance with product postmarketing approval requirements
• 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.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
• Provides leadership by communicating and providing guidance towards achieving department objectives.
• Interfaces with a variety of management levels on significa