Manager Of Regulatory Affairs Jobs

Job Title: Manager, Regulatory Affairs Promotional Manager Company: Hospira Location: Lake Forest, IL Description: Aspire to set new standards for excellence. A global specialty pharmaceutical and medication delivery company, Hospira is Advancing WellnessTM by discovering, developing, manufacturing, and marketing high-quality hospital products and technology solutions. We're among the leaders in our field, backed by decades of experience. We use unique methods to create dramatic results and we empower each employee to explore new ways of improving the safety and effectiveness of patient care - with integrity, speed, and a sense of personal accountability to patients around the world. As a leader and an innovator, we take great care to hire, develop, and keep the right people - people of integrity who are motivated by challenges, take ownership of their careers, embody our values and embrace entrepreneurial spirit. Manager, Regulatory Affairs Promotional Manager In this role, you will have the opportunity to work in a burgeoning arena within Hospira; biologic and proprietary compounds. These platforms are anticipated to become key drivers of Hospira's future growth. You will assure that advertising and promotional materials are in compliance with US government requirements as well as support and guide teams in relation to DDMAC/FDA requirements. This will encompass, but not limited to, evaluating manufacturing and labeling changes and promotional materials for regulatory impact and ensuring compliance with applicable regulations; providing regulatory support and expertise with regard to the development of pre-approval and promotional communication plans and materials; and developing & maintaining a thorough understanding of government policies, regulations and guidelines related to labeling, promotion and advertising. To be successful in this position, you must possess: Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related field. Master's degree preferred. 5-8 years experience in the pharmaceutical industry. 3 years experience in regulatory affairs preferred. Experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency guidances and regulations. Previous experience with DDMAC and promotional review preferred. Ability to challenge scientific arguments and understand business needs Demonstrated negotiation, interpersonal and communication skills. Hospira offers an agile, yet balanced work culture and the types of compensation and benefits you'd expect from an industry leader. We provide the tools and resources you need to reach and exceed your career goals through professional development, education reimbursement, and much more. To what do you aspire? Learn more about us and apply online: Click Here to Apply Req #:5868BR As an equal opportunity/affirmative action employer, Hospira embraces diversity of thought and cultural perspective and fosters an environment of empowerment, fairness and respect.

Job Title: Manager, Regulatory Affairs Company: Boston Scientific Location: Boston, MA Description: Manager, Regulatory AffairsRequisition ID 31473Full/Part Time xLocationMarlboroughMADescriptionSummary:Responsible for multiple product lines, technologies and specialized functions. Devotes a significant portion of time to managerial, leadership and employee development responsibilities.Responsibilities:Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team.Provides day to day management of Regulatory Affairs function for major divisional business segment.Establishes project priorities, allocating resources and workload.Provides technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies.Reviews and edits submissions prepared by staff.Represents Regulatory Affairs at management updates.Provides long range strategy formulation.Develops and implements departmental policy and procedures.Provides Regulatory Affairs training/mentoring to other employees.Support and maintain quality initiatives in accordance with BSC Quality Policy.Continuously assess ways to improve Quality.Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.Develops and implements regulatory strategies for new and modified products.Oversees preparation and submission of global regulatory applications as well as internal regulatory file documentation.Oversees review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.Supports highly technical or major business segment product lines, special projects and strategic initiatives.Qualifications:Bachelor s degree or equivalent work experience, preferably in a scientific or technical discipline.Professional certification(s) preferred.9 plus years Regulatory Affairs medical industry experience preferred.5 plus years managerial/supervisory experience preferred.Overall understanding of global regulations.Strong technical knowledge of medical products.Comprehensive understanding of relevant medical procedures, practices, terminology, and products.Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.Thorough knowledge of product development process and design control.Excellent research and analytical skills.Excellent written and oral communication, technical writing and editing skills.Ability to effectively manage multiple projects.Strong organizational, leadership, interpersonal and influencing skills.Proficiency with Microsoft Office.Working Conditions:General office environment, with potential (domestic and international) travel to BSC facilities and other meetings

Job Title: Regulatory Affairs Manager, Labeling Company: Fidelis BioPharm Location: Washington, DC Description: Regulatory Affairs Manager, Labeling Ensure that Core Data Sheets, Package Inserts and corresponding regional prescribing information provides all essential information for the safe and effective use of the product. Liaise with senior management as needed to resolve critical labeling issues BS/MS in a scientific discipline with at least 4+ years of increasing documented success in regulatory affairs (preferably in labeling) with an additional 5 years or more in a relevant field of pharmaceuticals/biotechnology

Job Title: Regulatory Affairs Manager Company: Cybercoders.com Location: Sunnyvale, CA Description: Regulatory Affairs Manager Regulatory Affairs Manager - Medical Device - FDA Skills Required - Regulatory Affairs, Medical Device/IVD/Pharma/Healthcare, IDE, PMA, MDR, 510KRegulatory Affairs ManagerIf you are a Regulatory Affairs Manager with experience, please read on! Our client is a dynamic medical device company experiencing tremendous growth. We are looking for an experienced Regulatory Affairs Manager to provide regulatory support and assist with various ongoing projects in order to remain in with all FDA and other U.S. and international regulatory requirements.What you need for this position:- Regulatory Affairs experience in medical devices, IVD, pharmaceutical or other healthcare industry- Experience with MDRs, IDEs, PMAs and 510k filings- Interventional cardiology is a plusWhat you'll be doing:- Prepare regulatory filings such as IDE, PAM and Design Dossier submissions- Attend Project Team Meetings - Coordinate regulatory submissions- Assist with preparation of presentations to FDA reviewers and/or inspections as needed- Review and approve Product Incident and MDR reports- Review and approve Engineering Change Orders, CAPAs, NCRs, etc.- Ensure compliance with FDA and European regulations and guidelines as well as relevant company SOPs and protocols- Prepare internation product registrations and licensing documentation- Maintain information in various compliance databases and produce reports as neededWhat's in it for you:- Competitive Pay- Outstanding benefits- Join a company that is experiencing tremendous growth- Excellent career opportunities- Great work environmentSo, if you are a Regulatory Affairs Manager with experience, please apply today!

Job Title: MANAGER OF REGULATORY AFFAIRS Company: MRINetwork Location: Milton, MA Description: For over four decades, The Richmond Group USA, one of the nation’s most established and successful search firms, has been helping candidates achieve their career dreams and goals by matching them with client companies located across the nation.  Let the highly trained search professionals at The Richmond Group USA work for you! One of our top clients located in Massachusetts, an industry leader in cell based therapies, is actively seeking qualified candidates for the role of MANAGER OF REGULATORY AFFAIRS.  ADVANTAGES OF THIS OPPORTUNITY: CHANCE TO MAKE A DIFFERENCE - In this role you will have the opportunity to play an integral role in the expansion of their product line into the European market. BEST OF BOTH WORLDS - Our client provides a small company atmosphere, while at the same time providing an element of stability, since they have been around for a while, and they have a very robust pipeline that includes a blockbuster product already on the market! PHENOMENAL GROWTH POTENTIAL - As the RA Manager, you will have the opportunity to continue to expand the department and grow along with the company.  TO BE MOST SUCCESSFUL IN THIS ROLE YOU WILL NEED: BS in a scientific discipline with at least 10+ years of relevant industry experience within Biotech with at least 6+ years in a Regulatory Affairs function within biologics Proven experience with IDE, PMA and 510(k) submissions and negotiations with the FDA Prior experience with investigational product and marketing authorization applications in the US and EMEA  If you are interested in this or future opportunities in your area, please send a Word-Formatted resume to Register to View and we will contact you when opportunities arise that match your geography and experience.  All inquiries are kept confidential and your information will not be shared without your prior approval. TRG an industry leading recruiting firm specializing in the placement of BioEnergy, Biotechnology, Pharmaceutical, Medical Device & Diagnostic candidates with backgrounds in Regulatory Affairs, Quality Assurance (QA), Quality Control (QC), Clinical Research, Process Development, Analytical Development, Formulation Development, Clinical Testing & Strain Development.  If you have experience in any of these areas and are looking for career growth opportunities, then we would love to hear from you. BioTech Specialty Job Board:  http://www.richgroupusa.com/New_web/Specialty_Homepage_BIOTECH.htm   BioTech Regulatory & Quality Professionals Network on Linkedin: http://www.linkedin.com/e/gis/ Register to View 18E2

Job Title: Associate Director Regulatory Affairs - CMC Company: Top Echelon Network Location: Foster City, CA Description: Reporting to the Head of CMC Regulatory Affairs this person will responsible for leading regulatory activities for assigned projects.They will prepare submissions that are technically complex. This requires extensive interaction with departments outside of Regulatory Affairs. They will be responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned products.This person must hold a scientific degree and have at least 10 years in progressive experience in Regulatory Affairs. An advanced degree is preferred. Director people management and experience as the Regulatory representative on project teams is required. This person needs to fully understand the regulatory process and be able to suggest and support changes to the system.   See all jobs in Foster City CA

Job Title: Director of Regulatory Affairs Company: MRINetwork Location: Detroit, MI Description: 10 years in Regulatory Affairs in a biopharmaceutical setting, including 3 years of experience at the manager level or above. Responsibilities include formulating and implementing Corporate Regulatory Affairs policies and procedures, developing the strategic direction for all Regulatory Affairs activities, and providing strategic Regulatory Affairs input to all product development programs. Will also represent Regulatory Affairs in all M&A activities, and is the major interface with all state and federal regulatory agencies.   Strong CMC is a plusMust have a complete understanding of the organization and function of the FDA. Expertise in European regulations a plus. Excellent communication skills required.Must have vaccine and/or biologics experience

Job Title: Regulatory Affairs Manager - Company: Location: San Francisco, CA Description: COMPANY: Medical Device Start-Up JOB DESCRIPTION: The Manager of Regulatory Affairs is responsible for the management and strategic leadership of the Regulatory Affairs department. This role includes allocating and managing department resources to accomplish department and business objectives. JOB REQUIREMENTS: - Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and business objectives. - Provides direction and guidance to staff/consultants who posses experience to exercise significant latitude and independence in their assignments. - Builds strategic partnerships with R&D and Clinical to accomplish departmental and business objectives. - Builds partnerships with FDA, VMI?s notified body, EU competent authorities and other regulators. - Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. - Monitors compliance with company policies and procedures (e.g. compliance with FDA, EU regulations, etc.). - Makes decisions regarding work processes or operational plans and schedules in order to achieve department/business objectives. - Develops, monitors, and appropriately adjusts the annual budget for department/projects. - Assess proposed/new regulations and communicate new requirements to the organization. - Responsible for compliance with applicable VMI Policies and procedures. SKILLS AND EXPERIENCE: - Minimum of ten years experience in Regulatory Affairs and with a minimum of five years experience with medical devices and PMA/PMAS submission processes - General knowledge of catheter technologies, cardiac/cardiovascular anatomy & disease and electrophysiology clinical procedures/equipment EDUCATION: List minimum education required. - BS degree in Engineering or Life Sciences This is a FULL-TIME position, M-F If you are interested, please submit your resume by email (cut and paste text only, NO ATTACHMENTS), with REGULATORY AFFAIRS MANAGER in the subject line, your salary requirements and a brief description as to why you would be a good match for this position.

Job Title: REGULATORY AFFAIRS MANAGER – (medical devices) Company: Carestream Health Location: Rochester, NY Description: Employer Information About Carestream Health Carestream Health, Inc., formerly Eastman Kodak Company’s Health Imaging Business is an internationally recognized provider of medical and dental imaging systems, healthcare information solutions; molecular imaging systems; and non-destructive products. ONEX, one of Canada’s largest corporations, acquired the Eastman Kodak’s Health Imaging Division in a multi-billion-dollar transaction in May 2007. Upon closing, the business began operating as Carestream Health, Inc., an independent subsidiar....more info Job The Regulatory Affairs Department at Carestream Health is a division of the Corporate Technology Office. Activities are dedicated in support of product development and commercialization and post-market surveillance including adverse event reporting, international product registrations and oversight for medical device recalls. Our portfolio includes Class I, II and III devices some of which are exempt from premarket notification while others are PMA devices. Reporting to the CTO Regulatory Affairs, The Regulatory Affairs Manager provides post-commercialization and post-market regulatory support to Carestream medical device products both domestically and internationally. This includes regulatory support for current product engineering, manufacturing, servicing and post-market surveillance activities. The Regulatory Affairs Manager will be required to prepare product files for submission for Class I, Class II medical devices and compliance to domestic and international governments to obtain approval to market medical devices. The Regulatory Affairs Department offers you the opportunity to work in a very innovative and exciting environment where you will be exposed to and challenged with a broad spectrum of product submissions and global regulatory requirements. For the candidate who desires to continually develop and hone their regulatory skills this is a great job! This is a full-time, regular position, not a consulting role. Carestream Health offers very competitive compensation including excellent employee benefits and a great work environment. You must be authorized to work in the United States; company sponsored immigration is not offered. Relocation assistance is available for qualified candidates. Primary Responsibilities Assist in preparation of post-marketing approval applications, such as Pre-Market Application (PMA) Supplements. Communicates with commercialization Regulatory Affairs manager regarding Product Hazard Risk Management, significant post-launch design changes etc. Prepares license amendments and annual reports to Therapeutic Directorate of Health Canada regarding Class 1 and Class 2 medical devices Provides documents supporting international product registrations, approvals or licenses for additional marketing approvals after product launch. Proficient with, communicates and verifies compliance with new regulatory requirements that impact product that is on the market Works closely with cross-functional teams and individuals in providing regulatory oversight for post-launch product development activities and updates post-commercialization deliverables such as the Declaration of Conformity, Technical Construction File, etc. Works with current product engineering/manufacturing staff to review and approve product modifications, including engineering change orders, drawings, test plans & reports, field manual or parts list updates or supplier certifications Participates in Corrective Action Teams post-launch. Reviews and approves all post-launch customer publications, labels, labeling and marketing advertising and/or promotional materials for products marketed by the company. Responsible for coordination, documentation and submission of Medical Device reportable events. Provides training on applicable medical device regulations. Owns Regulatory Affairs Standard Operating Procedures processes that apply. (i.e. Post Market Surveillance, EMDR Process, Electronic Radiation Report, etc.) Participates in product quality investigations and Regulatory Agency inspections including internal and external audits Functions as a product line expert within Regulatory Affairs. Provides guidance and support to QA and QE for post market adherence to GMPs, QSRs, and GCPs. To apply for this position, please visit the careers section of our website at www.carestreamhealth.com and insert “999BR” into the search field. Carestream Health is an Equal Opportunity Employer. NOTES: Employer will assist with relocation costs

Job Title: Manager/Sr. Manager Regulatory Affairs (Post Approval) Global Pharma Co Opening US HQ in NJ Company: Cornerstone Search Group, LLC Location: Morristown, NJ Description: Manager/Sr. Manager Regulatory Affairs (Post Approval) Global Pharma Co Opening US HQ in NJ – Ground Floor Oppty Summary: Provide Sr. Management members of the U.S. affiliate and the Parent Company with advice and guidance regarding complying with US FDA regulatory requirements for its multiple approved and marketing FDA drugs. Location: Morristown, NJ Area Attractive Features About This Company: Join an established billion dollar international pharmaceutical industry leader opening its first USA Headquarters in NJ. Join an established international pharmaceutical company opening its first USA Headquarters that already has multiple FDA approved drugs marketed in the USA generating several hundred million dollars in annual revenue. Join an international pharmaceutical company that generates a very strong profit. Very attractive opportunity to "get in" on the ground floor of this company as it starts to build its USA team Attractive features about this position: High exposure position: you will report directly to the CEO and you will interact with multiple Sr. Management team members of the US-based company and the internationally-based parent company. Make a difference: you will be the top Regulatory Affairs professional in the company where you will be able to see the actual impact of your advice, guidance, decisions and actions. Challenging and diverse responsibilities: your responsibilities will be broad and range from overseeing SOPs to handling customer complaints to communicating directly with FDA representatives. Ground floor opportunity: you will be the first Regulatory Affairs professional hired by the company and thus will have an opportunity to create the first set of footprints for the position. Responsibilities: Provide Sr. Management members of the U.S. affiliate and the Parent Company with advice and guidance regarding complying with US FDA regulatory requirements for the company’s multiple FDA approved drugs that are being marketed in the US. This position’s responsibilities will include, but not be limited to, performing the following: Ensure appropriate SOPs are established to appropriately handle/process customer complaints (e.g. complaints from patients, pharmacists, distributors…) Communicate with FDA representatives (e.g. respond to FDA inquiries, provide the FDA with up-to-date information regarding its filings…) Review labeling content and marketing materials to ensure compliance with FDA regulations and guidelines. Manage a strategic relationship with an external CRO responsible for maintaining the Company’s approved NDA filings. Requirements: BA/BS degree in one of the life sciences 5 or more years of Regulatory Affairs experience gained working for a Pharmaceutical/Biotechnology company Regulatory Affairs experience in one or more of the following areas is a plus: FDA interactions: communicating directly with FDA representatives Labeling & marketing materials: reviewing labeling and marketing materials to ensure compliance with current FDA regulations and guidelines SOPs: ensuring appropriate SOPs are established and maintained for processing/handling customer complaints Filings: performing necessary actions/steps to ensure FDA filings are kept up-to-date and satisfy FDA filing requirements Advice/guidance: providing advice and guidance to Sr. Management regarding various regulatory matters Good communication skills (verbal and writing skills) The ability and willingness to travel domestically and internationally as required Cornerstone’s Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information. Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact: Cliff Miras (initial contact via email is preferred) Co-founder & Managing Partner Cornerstone Search Group, LLC 6 Campus Drive Parsippany, NJ 07054 P Register to View ext 711 Email Steven Raz or Research Team: Register to View or Register to View Web/URL: www.cornerstonesg.com About Cornerstone Search Group, LLC Cornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets. Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates. Building better companies. Building better careers.® Other Opportunities Cornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist. Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.