Regulatory Affairs Project Manager - Abbott Laboratories : Job Details

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.

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,nutritional'sand 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'llalso 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 andFreeUeducation benefit - An affordable and convenient path to getting a bachelor's degree.

• A company recognized asa great placeto 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.

• Cardiac Rythm ManagementBusiness Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device andCardiac Rythm Management solutions

The Opportunity–

WeareseekingaRegulatoryAffairs Project ManagertojoinourCardiacRythmManagementteaminSylmarCA. Asanindividualcontributor,thefunctionofaRegulatoryAffairs Project Manageristocombineknowledgeofscientific,regulatoryandbusinessissuestoenableproductsthataredeveloped,manufacturedordistributedtomeetrequiredlegislation. Theindividualhasdepartment/group/sitelevelinfluenceandisgenerallyrecognizedasanexpertresourcewithinthedepartment. Theindividualmayshareknowledgeandexpertisewithothersinsupportofteamactivities. Theindividualmayidentifydataneeded,obtainthesedataandensurethattheyareeffectivelypresentedfortheregistrationofproductsworldwide.

WhatYou'llWork On -

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include:

Strategic Planning:

• 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 ofinitialproduct concepts and provide input to senior regulatory management

• Assist in the development ofmulticountryregulatory strategy and update strategy based upon regulatory changes

• Assistin regulatory due diligence for potential and new acquisitions

• Utilize technical regulatory skills to propose strategies on complex issues

• Determinesubmission 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

• Develop and mentor regulatory professionals

Premarket:

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing

• Compile, prepare,reviewandsubmitregulatory 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 andsubmitapplicable reports and ensureappropriate responsesaresubmittedto regulatory authorities

• Evaluate proposed preclinical,clinicaland 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

Postmarket:

• Oversee processes involved withmaintainingannual licenses, registrations,listingsand patent information

• Ensure compliance with productpostmarketingapproval requirements

• Review and approve advertising and promotional items to ensure regulatory compliance

• Ensure external communications meet regulations

• Develop,implementand manageappropriate SOPsand systems to track and manage product-associated events

Job specific responsibilities may include(choose applicable areas and expand asappropriate);

• Medical writing

• Advertising and promotion

• Labeling

• Restricted substancesreporting asrequired(e.g.REACH)

• Compendial / standards

• Import / export

• Country specific regulatory support

• Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues,and mustassurethat 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 indeterminingtechnicalobjectivesof assignments. Completed work is reviewed from arelatively long- term perspective for desired results.Individual isrecognized asa discipline expertandresourcein regulatoryaffairs.

Influence/Leadership:

• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.

• Provides leadership by communicating and providing guidance towards achieving departmentobjectives.

• Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.

• May lead a cross-functional or cross-divisional project team.

• Provides technical leadership to business units.

• Acts as a mentor to less-experienced staff.

• Exercises judgment independently.

Planning/Organization:

• Creates immediate to long-range plans to carry outobjectivesestablishedby top management.

• Forecasts project related needs including human and material resources and capital expenditures.

Decision Making/Impact:

• Assignments are expressed in the form of objectives

• Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.

• Consequences oferroneousdecisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Required Qualifications–

• BachelorsDegree (± 16 years) ,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 lawishelpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

• Minimum 4years experiencein 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. Note: Higher education may compensate for years of experience.

Background / Skills / Knowledge Regulatory Knowledge of (as applicable):

• Regulatory history, guidelines, policies, standards, practices,requirementsand precedents

• Regulatory agency structure,processesand key personnel

• Principles and requirements of applicable product laws

• Submission/registration types and requirements

• GxPs(GCPs, GLPs, GMPs)

• Principles and requirements of promotion,advertisingand labeling

• International treaties and regional, national,localand territorial trade requirements,agreementsand considerations

• Domestic and international regulatory guidelines,policiesand regulations

• Ethical guidelines of the regulatory profession, clinicalresearchand regulatory process

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

• Write and edit technical documents

• Negotiate internally and externally with regulatory agencies

• Plan and conduct meetings

Cognitive Skills or Ability to:

• Pay strong attention to detail

• Manage projects

• Create project plans and timelines

• Juggle multiple and competing priorities

• Think analytically with goodproblem solvingskills

• Organize and track complex information

• Exercise judgment within broadly defined practices and policies in selecting methods,techniquesand evaluation criteria for obtaining results

• Has broad knowledge of various technical alternatives and their potential impact on the business

• Exercise good and ethical judgment within policy and regulations

• Use in-depth knowledge of business functions and cross group dependencies/ relationships

• Define regulatory strategy

• Follow scientific arguments,identifyregulatory scientific dataneedsand solve regulatory issues

• Perform risk assessment or analysis

• Lead functional groups in the development of relevant data to complete a regulatory submission

Preferred Qualifications–

• Experience working with Windchill or similar Product Lifecycle Management (PLM) software

• Experience writing procedures and SOPs

• Experience working with 510k and PMA submissions

The base pay for this position is $112,000.00– $224,000.00. In specific locations, the pay range may vary from the range posted.