Manager Of Regulatory Affairs Jobs in Illinois

Job Title: Regulatory Affairs Manager Company: The Cambridge Group Ltd. Location: Highland Park, IL Description: Regulatory Affairs ManagerThe Regulatory Affairs Manager will have responsibility for providing regulatory strategy and support for the company’s Regenerative Medicine business. In this position, the candidate will interact with a global team involved with the development and maintenance of our cellular therapy and biosurgery products.  The incumbent will develop and execute regulatory plans for complex projects including new and existing products within the company’s stem cell, surgical sealing and hemostatic product portfolio.  Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.  Ensure project teams and business objectives and deliverables are aligned with regulatory strategy. Monitor applicable regulatory requirements, assure compliance with the company and external standards. Assess impact of new regulations and provide feedback.  Gather regulatory intelligence regarding the global regulatory environment and competitive products.  Develop and document sound regulatory decisions and justifications.  Represent or lead the RA function on assigned cross-functional project teams.  Communicate proactively and report to regulatory authorities.  Maintain appropriate communication within the RA function and other functions primarily at the project team level.  Initiate, manage and maintain operational activities in support of new and existing marketing authorizations.  May provide direct supervision of individuals including mentoring and performance management.  May review promotional material or SOP’s for compliance with local and global regulations.  The successful candidate must have sound basis of regulatory knowledge related to biologic or medical device products (combination product knowledge is an advantage).  Working regulatory knowledge of preclinical and clinical product development, as well as regulatory experience with biologics or medical device manufacturing.  Good scientific knowledge.  Ability to manage multiple complex projects and timelines in a matrix team environment.  Demonstrated interpersonal and collaboration skills, including strong negotiation skills. Strong oral and written communication and presentation skills.  Ability to independently identify compliance risks and escalate when necessary. Ability to lead and coach others.  A minimum of 4 years regulatory experience in RA or related field, including managing people or projects is required. A BS degree or equivalent in related field, but relevant post graduate degree is preferred.Please refer to job code SD7068 when responding to this ad.

Job Title: Regulatory Affairs- Manager/Director Company: Abbott Laboratories Location: Abbott Park, IL Description: Regulatory Affairs – Managers / Directors At Abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. Today, 72,000 Abbott employees are doing work that matters. We are currently seeking for talented Regulatory Professionals to join our organization at various sites. Positions include, but are not limited to Manager of Documentation and Labeling, Regulatory Managers, Associate Directors, and Directors. The divisions currently seeking motivated candidates are Abbott Diabetes Care, Abbott Diagnostics, Abbott Molecular, Abbott Vascular, and Abbott Pharmaceuticals. Locations: California, Illinois, Massachusetts, New Jersey Depending upon the position, responsibilities may include: Development and implementation of strategies to insure earliest product introduction into domestic and international markets. Handles/manages regulatory submissions activities and Medical Device Reporting. Insures labeling, advertising and promotional activities meet applicable regulatory requirements. Will interact with regulatory agencies as required Manage and maintain compliant change control system for controlled documents that include product labeling, ensuring that documentation for change packages is approved Depending upon the position within Abbott’s Pharmaceutical division, responsibilities may include: Interacts with FDA on key projects and issues including direct negotiation with review division personnel, and DDMAC reviewers. Direct and manage the preparation and review of regulatory documentation for agency submission. Develop and implement internal and external strategies to proactively take lead to respond to legislation/guidance with impact on Abbott businesses. Draft and/or edit internal process and standards documents relating to publishing and publishing deliverables. Assess and resolve labeling issues taking into account global regulatory requirements Education Requirements: Bachelor’s Degree; advanced degree preferred Depending upon the position, requirements may include: Minimum 5 years of regulatory experience that includes US and/International experience Management/Project Management experience Knowledge and experience working with FDA and ISO regulations Knowledge of regulations and standards affecting IVDs and Biologics. International experience (PAJAME, Latin America, Europe) Interactions with regulatory bodies 510 (k) submissions PMA submissions (which ones-please be specific): Regulatory labeling Regulatory promotions (product marketing, advertising, DDMAC) Medical Device Reporting Previous experience working with a change control system in a regulated industry Familiarity with electronic document control systems preferred. Strong therapeutic background Prior experience working with Preclinical, Clinical, CMC organizations (Abbott’s Pharmaceutical Division) Experience with publishing-related software tools including Documentum, Adobe Acrobat, and MS Word, etc (Abbott’s Pharmaceutical Division) Submissions (NDA, INDA, ANDA, PLA, NADA, BLA) (Abbott’s Pharmaceutical Division) Experience with drug development/product lifecycle (Abbott’s Pharmaceutical Division) Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence. Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference. Through our diverse healthcare businesses, we connect people and potential in ways that no other company can. Discover a world of opportunities at Abbott. EEO Statement: At Abbott, we believe that diversity drives innovation. Innovative thinkers who are passionate about the work they do, Abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.

Job Title: Manager Regulatory Affairs Company: The Cambridge Group Ltd. Location: Highland Park, IL Description: Manager Regulatory AffairsThe Manager Regulatory Affairs will develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.  The candidate will represent or lead the RA function on assigned cross-functional project teams.  Monitor applicable regulatory requirements; assure compliance with company and external standards.  Establish appropriate communication within RA and other functions primarily at project level.  Perform gap analysis and propose solutions.  Develop and document sound regulatory decisions and justifications.  Ensure project teams and business objectives and deliverables are aligned with regulatory strategy. May provide direct supervision of individuals.  May review promotional material or SOP’s for compliance with local and global regulations.  The incumbent must have sound basis of Regulatory knowledge.  Documented 510(k) submission experience.  Solid scientific knowledge. Ability to manage complex projects and timelines in a matrix team environment.  Strong oral and written communication and presentation skills.  Demonstrated interpersonal skills including strong negotiation skills.  Ability to independently identify compliance risks and escalate when necessary. Ability to lead and coach others. A bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. A higher degree/PhD will be an advantage.  Up to 5% travel may be required.Please refer to job code SD7069 when responding to this ad.

Job Title: Manager, Regulatory Affairs (03) Company: Global Healthcare Location: Chicago, IL Description: Position:  Global healthcare company is seeking a dynamic, self starting individual to assume ownership of assigned regulatory projects. In this self directed project role the selected individual will be responsible to perform the following functions: Provide global regulatory input for new product development and on-market support of software controlled medical device products including software accessories, interfaces, and associated single use medical devices. In the performance of those duties the individual will execute regulatory plans for those projects including new products and maintenance of licenses/authorizations for existing marketing products. Additionally, he/she will ensure that regulatory submissions and design documentation meet corporate and departmental standards with respect to technical expertise and will resolve any conflicts relating to the design.To be considered for this position you must possess a bachelor’s degree in engineering or in a scientific discipline in addition to 5-7 years directly transferable 510k experience with software driven medical device products for a global market. Proven ability to mentor, lead, and positively influence others in meeting project timelines will be essential for success.

Job Title: Manager, Regulatory Affairs Company: Astellas Location: Deerfield, IL Description: Astellas is the bright spot in the pharmaceutical industry – not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!Member of Astellas global project teams, including oncology and urology extended regulatory teams, and task forces requiring the interpretation of regulations and guidelines. Responsible for developing regulatory submission strategy for assigned projects, in collaboration with Global Regulatory Lead and/or RA management. Identifies data requirements and prepares regulatory submission packages, which may include INDs, CTAs, IMPDs, NDAs , MAAs, responses to deficiency letters and health authority queries. Maintains filings and approvals.. REQUIREMENTS - QUALIFICATIONS: Manager, Regulatory Affairs Manages technical documents for preparation, review and submission to global regulatory agencies, as required. Compiles INDs, CTAs, IMPDs, and NDAs, amendments & supplements, as well as responses to questions from regulatory agencies. Assesses presentation of scientific data against regulatory requirements and reviews submissions against regulatory strategy.Ensures compilation and transmittal of submissions are within defined schedules and meet regulatory agency requirements and Astellas established standards/SOPs.Develops approach for new assignments having less-defined regulatory frameworks with management oversight.Regularly interacts with functional peer groups internally and externally, occasionally with senior management.May interact with FDA review staff. Participates in regulatory agency meetings in collaboration with senior RA staff.Advises global teams on US regulatory requirements. Interprets regulations and guidelines to support global submission strategies for assigned projects, in collaboration with Global Regulatory Lead and/or RA management.Provides support for international registrations and licensing opportunities.Maintains all assigned projects as compliant with regulations and guidelines. Addresses complex and diverse problems with decision making that impacts area of responsibility. Actively identifies, escalates and advocates for the optimal solution while informing the necessary audience of the benefits and drawbacks of each possibility.Interpreting regulations and guidances and the communication to RAQA and the project teams. Balancing multiple projects with conflicting timelines. Developing familiarity with all aspects of drug development. Maintaining working relationship with health authorities while still promoting the company position.• Bachelor’s degree in scientific or related discipline.• At least six years previous industry experience; three years in RA.• Ability to apply scientific knowledge or technical expertise to regulatory issues and product development.• Experience in an aspect of pharmaceutical drug development.• Knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.• Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project ream members.• Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.• Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and other Astellas groups.• High integrity with respect to maintenance of proprietary, confidential information.• High computer literacyAstellas

Job Title: Manager, Regulatory Affairs Company: Location: Chicago, IL Description: Apply here "http://www.jobvite.com/j/?aj=o0uhVfwq&s=craigslist" Manager, Regulatory Affairs Company Overview As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. We are a research-based company, enhancing our R&D pipeline by concentrating our management resources. Takeda's in-house ethical drugs are marketed in around 90 countries worldwide and are recognized as the brand leader in major countries worldwide. Our management philosophy, "Takeda-ism" is the basis of our business as we continue to grow and prosper. Takeda is an energetic company that attracts and retains well-qualified personnel from all over the world. We strive to maximize the capabilities of our work force by creating a corporate climate that is appealing and encouraging to skilled and ambitious individuals. This will entail preparation of a global personnel program that, first and foremost, fairly evaluates and rewards employees for the results they achieve. Job Description We are currently seeking a Manager, Regulatory Affairs to provide guidance and expertise to the global project team. General responsibilities include: identifying regulatory requirements, manage all regulatory activities for lead compounds, mentor junior regulatory personnel, and communicate with the FDA at the Division level. Responsibilities: Provides regulatory guidance and expertise to global project team on the assigned project(s) of responsibility. Identifies regulatory requirements and data reporting deadlines to ensure registration and approval of drug products. Plans/manage/execute all regulatory activities for lead compound(s) in development and supports regulatory activities for assigned marketed product(s) of responsibility. Mentors and provides guidance to more junior regulatory personnel. Provides regulatory support in FDA meeting preparation. Interacts with the Project Management Staff at the FDA Divisional level. May interacts with other levels of FDA within the Division(s) of responsibility Independently provides regulatory advice and guidance to the development team on most development issues. Plans, executes and manages regulatory submission for key compounds in various phases of development, including post-approval life cycle management activities for marketed products. Ensure regulatory compliance of marketed products. Manages FDA meeting preparations. Acts as the lead regulatory representative at some FDA meetings. Communicates with the FDA at the Division level and state regulatory agencies as required. Provides input into the product development strategy and executes implementation. Manages the preparation and submission of major regulatory submissions. Provides input into regulatory risks assessment and makes recommendations relative to the overall strategy. Manages others drug development regulatory professionals. Requirements BS/BA Degree and 4+ years of pharmaceutical industry experience to include 2+ years of increased regulatory responsibility. Knowledge of FDA regulations. Understanding of scientific principles and regulatory/quality systems relevant to drug development Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings. Travel Requirements Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 20% travel. Integrity in All That We Do! Takeda's basic human resource principal is to "develop a high-performance, results-oriented culture within our organization with motivated employees who take pride in and find a sense of accomplishment from their work." To that end, we provide a comprehensive compensation and benefits package designed to promote the health and happiness of our valued employees and their families! Apply today and start a quality career with Takeda!

Job Title: Regulatory Affairs Manager Company: Fenwal Location: Lake Zurich, IL Description: Fenwal is a global leader in medical technologies focused on improving blood safety and availability for patient care.  A $600+ million business, Fenwal is a growing company that develops leading products, services and technologies used to collect, process and store blood and its vital components. Over 4000 people around the world work for Fenwal, helping each day to improve people’s lives while developing a rewarding career. This position is located in our corporate office in Lake Zurich, IL We currently have an opportunity in our Regulatory Affairs area for a Regulatory Manager who will act as regulatory product owner responsible for preparing regulatory strategies, change control and submissions for Fenwal software driven devices world-wide. We are seeking a “lead by example” individual with strong technical depth. The position will focus on post-market regulatory support and new product development strategies and submissions for medical device systems and software used in the blood banking industry.  Responsibilities include:·         Independently plan and manage regulatory strategies and submissions for complex new product development and change control projects.·         Interpret regulations and standards for software driven medical devices for R&D core teams to help develop product definitions consistent with regulatory requirements and business needs. ·         Act as core team regulatory lead to represent regulatory affairs on assigned product and project teams for software driven medical devices or stand-alone software for medical purposes.·         Establish regulatory strategies that align with world-wide objectives.·         Provide regulatory advice, review and approval of technical documents including product specifications, clinical protocols, test plans, design control documentation and risk assessments. ·         Keep apprised of global regulatory requirements and inform product teams of upcoming changes in the regulations.·         Interact directly with regulatory agencies to answer questions and move submissions forward. Establish and maintain rapport with agency contacts. ·         Review and approve product labeling and advertising for compliance to applicable regulatory requirements.·         Provide regulatory expertise and technical knowledge to fulfill complex post-market requirements.Required Skills and Experience:·         Bachelor’s degree or equivalent experience in related scientific discipline (e.g. engineering, software)·         5 years of related experience in regulatory affairs including experience directly interacting with project teams for software driven medical devices·         US submission experience.(Development/author for IDE, 510(k), and/or PMA for software driven medical devices)·         Direct FDA interaction to drive clearance/approval of medical device application·         Excellent written and verbal communication skills·         Ability to think strategically, exercise independent judgment and problem solve·         Ability to independently identify compliance risks and escalate as necessary·         Experience working with project teams on change control for on-market products·         Experience managing multiple projects and deadlines·         Ability to work in a multi-functional team environment Other Desired Skills and Experience:·         Global regulatory experience.·         Knowledge of European Essential Requirements, MDD and CE Marking Fenwal, Inc. offers an excellent salary and benefits package including immediate medical, dental and vision coverage, as well as life insurance, disability, 401K with company match and profit sharing. Fenwal is an Equal Opportunity Employer. We encourage and support a diverse workforce.

Job Title: Science and Regulatory Affairs Director Company: McDonalds Location: Oak Brook, IL Description: About the Department: McDonald's Worldwide Supply Chain Management (WWSCM) department manages and executes strong working relationships with a global base of suppliers and AOW (Area of the World) product leaders. Worldwide Supply Chain strives to fuel system growth and value by providing best-in-class quality products and services at a competitive price through the deployment of resources tailored to manage each product category. The role of Worldwide Quality and Food Safety within WWSCM is to develop science-based standards, proactively engage on emerging issue management, and improve the customers experience across the counter through the delivery of Gold Standard quality. Job Description: As the Science and Regulatory Affair Director in the Worldwide Supply Chain Management of McDonald's Corporation, the prerequisites for this position are: Deep understanding of Food Science including Microbiology, Chemistry, Nutrition and Toxicology. Familiar with Food related regulations, guidelines, and references around the world. Able to aid the design of company's strategy on potential food related issues. Able to translate the science into potential impact on the business. Able to work with external and internal technical experts and business partners to effectively manage emerging issues around the world. Able to effectively communicate with internal and external stakeholders on food safety, quality and nutrition related policies, standards, and potential impact to McDonald's business. Productive team player willing to work with people with different cultural background. Effective on data analysis with Microsoft Office. Effective on project management. Willing to travel internationally. (30% international and 30% domestically) Minimum Requirements for position: Masters in food science, microbiology, chemistry, nutrition or related discipline required Bilingual preferred At least 7 to 10 years of experience in food related industry Strong familiarity with HACCP, CODEX, food safety and quality management systems Working knowledge of crisis management Strong computer skills with experience using Word, Excel, Power Point Strong verbal and written Communication skills required Experience in working in a strong team environment Demonstrate leadership in the areas of food safety and regulatory affairs Must have the ability to function within a team oriented environment and collaborate on multidisciplinary efforts

Job Title: Regulatory Affairs Manager Company: Abbott Location: Des Plaines, IL Description: Employer Information About Abbott At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. Job At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. Regulatory Affairs Manager Job ID 72572BR Des Plaines, IL PRIMARY JOB FUNCTION: Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control and performs global regulatory impact assessment Provides consultation/advice to regulatory specialist for change control and product development Provides regulatory direction/interpretation on team activities Interprets and applies regulatory understanding to support of products and teams Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. U.S. submissions may include Pre-IDE, IDE, 510(k), PMA and PMA supplements. Handles regulatory activities involved in documentation, labeling, field support Applies regulatory and technical knowledge to a wide variety of complex work assignments Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures. CORE JOB RESPONSIBILITIES: Responsible for implementing and maintaining the effectiveness of the quality system. Executes regulatory requirements in relation to product development, submissions, product maintenance, and project plans Implements Division Regulatory Strategy in specific product-related activities Provides risk benefit analyses on a daily basis for specific product area Basic understanding of laws and regulations related to the division and applies that basic knowledge and interpretation to the solution of issues and to product development and support Analyzes the input of cumulative product changes to current product submissions. Shares knowledge and expertise with others in department and on teams. Provides solutions to wide variety of difficult problems where analysis requires moderate degree of evaluation. Makes presentations to groups division-wide; recommends action or persuades the audience to commit to action; develops formats for reports and presentations. Prepares and aligns impact goals with department goals. Conducts division-wide regulatory training. Interacts and may lead project and division-wide cross-functional teams. Develops positive working relationships with peers in Regulatory Affairs and with project and division-wide cross-functional groups at the business team/management level. Participates in conflict resolution at the cross-functional team level. Makes plans to accomplish multiple activities/projects, establishes priorities to meet multiple demands, optimizes use of resources. Works on developing and improving new planning processes. Develops project timelines, including resource requirements. Implements project plans using resource, budget, and regulatory requirements to meet project goals. Follows GMP guidelines and procedures. Works within all GMP guidelines and procedures. POSITION ACCOUNTABILITY/SCOPE: For all products division-wide, advises and communicates to project, group or venture regarding complex regulatory strategies. Sign-off at team level within delegated parameters; first level approval for change control; may have second level approval authority. Release authority for labeling/sales/ promotional materials. Official correspondence with outside regulatory agencies are guided by management staff. Conducts basic negotiations and conflict resolution on routine product related issues with government agencies. Follows through on submission related activities to secure product approval. Directs own daily activities by utilizing team goals and division regulatory priorities. Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Files submission documents with government agencies with review by supervisory staff as needed.

Job Title: Manager, Regulatory Affairs Company: Discovery Solutions, Inc. Location: Chicago, IL Description: Manager, Regulatory AffairsLooking for a submissions specialist experience submitting ANDA and AADAs to the FDA.Bachelors Degree plus 3+ years submissions experiencePlease refer to job code Reg Affairs when responding to this ad.