Manager Regulatory Affairs - AMD
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 113,000 colleagues serve people in more than 160 countries.
At Abbott, we're committed to helping people live their 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, 103,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Abbott Molecular has an opening in its Des Plaines, IL site for the Manager -Regulatory Affairs.
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 DO
Core job responsibilities for this position may include:
- Determine and communicate submission and approval requirements to development teams.
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
- Utilize technical regulatory skills to propose strategies on complex issues and product lifecycle planning.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams and recommend solutions.
- Must function independently as a decision maker on regular 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.
EDUCATION AND EXPERIENCE, YOU’LL BRING
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
- 4-5 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 2-5 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.
- Regulatory Knowledge of (as applicable):
- Regulatory history, guidelines, policies, standards, practices, requirements and precedents
- Regulatory agency structure, processes and key personnel
- Principles and requirements of applicable product laws
- Submission/registration types and requirements
- GxPs (GCPs, GLPs, GMPs)
- Principles and requirements labeling
- International treaties and regional, national, local and territorial trade requirements, agreements and considerations · Domestic and international regulatory guidelines, policies and regulations
- Ethical guidelines of the regulatory profession, clinical research and regulatory process
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Communication Skills or Ability to:
- Communicate effectively verbally and in writing
- Communicate with diverse audiences and personnel
- Write and edit technical documents · Work with cross-functional teams · Work with people from various disciplines and cultures
- Negotiate internally and externally with regulatory agencies
- Plan and conduct meetings.
- Cognitive Skills or Ability to:
- Strong attention to detail
- Manage projects
- Create project plans and timelines
- Must be able to juggle multiple and competing priorities
- Think analytically with good problem-solving skills
- Organize and track complex information
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Has broad knowledge of various technical alternatives and their potential impact on the business ·
- Exercises good and ethical judgment within policy and regulations
- Uses in-depth knowledge of business functions and cross group dependencies/ relationships ·
- Possesses ability to define regulatory strategy
- Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues ·
- Perform risk assessment or analysis
- M.S. in a technical area or M.B.A. is preferred
- A Ph.D. in a technical area or law is helpful
- Advanced degree in a technical area or law is helpful. Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities