Manager Of Regulatory Affairs Jobs in New Jersey

Job Title: Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader - Company: CyberCoders Location: Edison, NJ Description: Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader - .body .body h4 .body .section tr.oddRow a, a:link, a:visited Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader - near Somerville, NJ This job is open as of 3/6/2010. Apply Now! Not a fit for this job? Search other Director Regulatory Affairs jobs! Are you an employer? Visit us for more info! Email this job to a friend - $1000 Location Somerville, NJ; Edison, NJ Salary $150,000 - $250,000 Education Bachelor of Science Category Management Experience Required At least 2 Years Short Description Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader - Required Skills Global RA, Regulatory Strategist, Director Regulatory Affairs, Associate Director, Oncology , Global, International, Submission, PhD, PharmD Recruiter Erin Beagle Date Updated 3/6/2010 Skills Required Global RA, Regulatory Strategist, Director Regulatory Affairs, Associate Director, Oncology , Global, International, Submission, PhD, PharmD Job Description Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader -If you are a Director or Associate Director of Regulatory Affairs with International experience, and preferably a Phd/PharmD degree, please read on!An exciting opportunity to work for a brand name, top pharmaceutical company providing regulatory strategy and oversight into foreign markets. What you need for this position:-Experience as a Global Regulatory Strategist for the Pharmaceutical industry is required.-Phd or PharmD is a huge plus-at least 5 years working for a pharma/biotech in regulatory affairs-8 years total industry experience-Multiple therapeutic area expertise-Experience leading a team and leading projects-Working knowledge of regulations for drug development and registration activities-Ability to multi task and communicate effectivelyWhat you'll be doing:-Develop regulatory strategy for assigned products in foreign markets-Manage follow up after regulatory submission, manages response by regulatory authorities-Provides strategic and operational direction for therapeutic area group and appropriate organization-Mentor and manage junior level staffWhat's in it for you:-Excellent compensation package, including stock options, long term incentives and bonus structure-Excellent working environment-Very low (10%) travel-Highly visible position within an internationally respected organizationSo, If you are a Director or Associate Director of Regulatory Affairs with International experience, and preferably a Phd/PharmD degree, please apply today!Must be authorized to work in the United States on a full-time basis for any employer. Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Not a fit for this position? Click Here to Search Other CyberCoders Jobs! Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, or you may also: Email your resume in Word to: Register to View **Please do NOT change the email subject line in any way. You must keep the JobID: CC HotJobAp : EB-DirectorRegAffairs -- in the email subject line for your application to be considered.*** Erin Beagle - Executive Recruiter - CyberCoders Other Jobs

Job Title: Regulatory Affairs Manager Company: Becton Dickinson Location: Franklin Lakes, NJ Description: BD Medical, Pharmaceutical Systems, working in partnership with the pharmaceutical industry, develops an array of drug delivery systems that are critical to the integrity and delivery of medicine. Pharmaceutical Systems is a team dedicated to a high purpose in a friendly work culture. Imagine working daily on solutions to healthcare needs, wherethe problems are global, and your teammates are multicultural and striving to be the best. We are proud of doing our part to further BDs mission to help all people live healthy lives!The Regulatory Affairs Manager has extensive regulatory experience in Medical Devices with strong leadership and strategic competencies. The Regulatory Affairs Manager is responsible for leading and developing the US Regulatory team, developing and executing the business strategy, and working in partnership with the Pharmaceutical Systems World-Wide business.Main ResponsibilitiesPosition is critical for the timely market introduction of BDPS products with complex regulatory requirements.Responsible for managing regulatory activities within a world wide business, and for continued interaction between the business, agents of the US Food and Drug Administration, and agents of Health Ministries of non-US countries. Supervises Regulatory Affairs personnel capable of developing strategies to obtain appropriate regulatory clearances, and assessing the type and amount of product performance data required, ensuring timely product approval.Manage regulatory information by organizing the regulatory awareness on any new regulation that may impact BDM-PS products. Maintain the knowledge and awareness of current applicable regulations and standards.Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assess potential impacts to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.Support to customers for regulatory advice and registration of their products.Regulatory impact assessment of changes in coordination with Change Control GroupParticipates on multiple cross-functional teams within BDPS.Independently manage multiple projects and meet required milestones.

Job Title: Regulatory Affairs Manager Company: GlaxoSmithKline Location: Parsippany, NJ Description: Provide operational and strategic support for Regulatory Affairs Teams. Responsible for regulatory support of products in various OTC categories such as Analgesics, Oral Healthcare, Cough/Cold, Dermatologics, Antacids, Laxatives, Dietary Supplements.Interact and collaborate with the multi-disciplinary teams to implement development, registration, and marketing strategies for assigned marketed products and projects.Coordinate the preparation and submission of regulatory filings (IND, NDA, 510K, etc)Critically review internal and external submission documents. Act as central RA coordinator for local RA functionsCollaborate with functional areas to support prompt and effective preparation of global submissions to regulatory agencies.Participate on project teams as requiredPerform regulatory review of labeling, claims and advertising, change controls for specific products/projects.GlaxoSmithKline REQUIREMENTS - QUALIFICATIONS: Regulatory Affairs Manager BS/BA degree in science field.A minimum of 5 years experience in the pharmaceutical industry (2- 3 yrs in Regulatory Affairs).Good written and verbal communication skills.Demonstrated ability to organize and prioritize assignments and meet timelines.Highly flexible and adaptable to changing priorities. Awareness and ability to work within areas of cultural differences.Knowledge and ability to use IT software technology.Working knowledge of CTD format is a plus.At least 3 -4 years experience in Regulatory Affairs.Regulatory experience with OTC drugs (Monograph and NDA).Experience with cosmetics, medical devices, and dietary supplements is a plus.Project management experience is preferred

Job Title: Assistant/Associate Director, Regulatory Affairs CMC Company: Forest Laboratories, Inc. Location: Jersey City, NJ Description: Provide strategic regulatory support to quality operations (QC/QA/Compliance), manufacturing, packaging, and component and product release sites - for Forest Laboratories, partners, and external Contract Manufacturing Organizations. Design, develop, and manage a Change Control system for Regulatory CMC department. Serve as primary point of contact across all groups to evaluate the CMC related changes and determine the appropriate filing category for all products. Track and monitor all submissions associated with specific change controls at all sites. Promptly communicate regulatory approvals to all impacted functional groups (quality, manufacturing, packaging, release sites, R&D, etc.) and/or other appropriate information in support of registrations. Represent Regulatory CMC in Health Authority Inspections and/or internal audits to support of quality and manufacturing groups. Provide support to quality, manufacturing, and R&D groups in supplier/vendor selection processes and qualifications. Procures all supportive internal documentation (data, reports, etc.) as well as external information (letters of authorization for DMFs, BSE/TSE certifications, etc.) in support of all regulatory submissions (pre-approval and post-approval). Interact and liaise with other internal regulatory CMC colleagues and keep them informed on all site/scale/manufacturing site changes in support of their projects and corporate objectives. Provide oral presentations and written reports as necessary to management on matters relating to CMC activities. Coordinate pre-submission meetings with regulatory agencies as needed. Education: BS/MS/PhD in Pharmacy, Chemistry, Chemical Engineering or a related discipline. Experience: Minimum 8+ years of relevant experience in a regulated environment. Direct experience (pre- or post-approval) interacting with the FDA is a plus. Hands on experience in pharmaceutical product development and/or manufacturing is preferred. Licensure/Credentials: Regulatory Affairs Certification (RAC) or a Certified Quality Engineer (CQE) Certification is desirable. Knowledge, Skills, and Abilities Strong working knowledge of manufacturing unit operations (including packaging) and Scale-Up and Post Approval Changes (SUPAC) Excellent verbal and written communication skills Ability to work under pressure and manage multiple projects simultaneously Detail/accuracy oriented Collaborative and willing to learn

Job Title: Sr. Manager, Regulatory Affairs Company: Forest Laboratories, Inc. Location: Jersey City, NJ Description: For all assigned products: -Represent Regulatory Affairs as a member of Forest Project Teams -Provide regulatory strategy to teams and management towards the filing and approval of New Drug Applications -Actively monitor and advice applicable team members and product managers of upcoming regulatory affairs deadlines and other critical dates (e.g. patent expiration) -Proactively solicit regulatory submittals from other company departments including: preclinical, clin/pharm, clinical development, commercial (marketing), and manufacturing. -Assure the proper management, retention, and version control of all applicable Regulatory Affairs and product documentation. -Prepare recurring regulatory reports for Global Therapeutic Area Assoc Direct review. -Coordinate activities for paper-based and electronic submissions with all global regulatory agencies. Prepare submission packages and on approval, submit materials to applicable agencies. -Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs. -Identify areas for improvement within daily functions, internal procedures, and regulatory agency interaction. -Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions. Prepare applicable management reports related to assigned products. -Maintain a high level of expertise through reading and participation at professional seminars, workshops. -Exercises outstanding judgment in all areas of responsibility Education, Licensure, & Certifications: -Bachelors Degree in life sciences required. -Advanced Science Degree or equivalent experience preferred. Required Experience: -Regulatory, professional with a minimum of 3 - 5 years of Pharma and regulatory affairs experience, including IND and NDA filings. -Basic understanding of the following functional areas (within the context of regulatory affairs): - Quality Assurance - Labeling - Promotion - Drug Safety - Licencing - CMC Technical Qualifications: -Knowledge of all relevant pharma regulatory procedures and reporting requirements -Experience with document management of INDs, IND Amendments, FDA Briefing Packages, and NDAs. Experience with CTD and e-NDA/e-CTD preparation preferred. -Strong technical background including proficiency in Windows, Microsoft Office Suite, and Documentum General Qualifications: -Superior communication skills in a team-based environment -Energetic, self-motivated, organized individual who is accustomed to working in deadline-focused, high-pressure entrepreneurial environment. -Ability to manage multiple simultaneous products/projects. -Proficiency in both written and verbal communications and presentations -Strategic, analytical thinker with strong business acumen -Proactive, disciplined, organized, and detail-oriented. -Demonstrates consistent logic, rationality, and objectivity when identifying significant problems and opportunities. Creative problem solver with the ability to establish systems and define standard practices. -Displays high level of integrity by remaining consistent in terms of what he/she says and does in terms of behavior toward others. -Willing team player capable of working collaboratively with colleagues in their department and in all functions -Strong predisposition toward customer service.

Job Title: Regulatory Affairs Manager Company: BD (Becton, Dickinson and Company) Location: New Brunswick, NJ Description: Title: Regulatory Affairs ManagerLocation: New Jersey-Franklin LakesBD Medical, Pharmaceutical Systems, working in partnership with the pharmaceutical industry, develops an array of drug delivery systems that are critical to the integrity and delivery of medicine. Pharmaceutical Systems is a team dedicated to a high purpose in a friendly work culture. Imagine working daily on solutions to healthcare needs, where the problems are global, and your teammates are multicultural and striving to be the best. We are proud of doing our part to further BD's mission to help all people live healthy lives!The Regulatory Affairs Manager has extensive regulatory experience in Medical Devices with strong leadership and strategic competencies. The Regulatory Affairs Manager is responsible for leading and developing the US Regulatory team, developing and executing the business strategy, and working in partnership with the Pharmaceutical Systems World-Wide business.Main Responsibilities* Position is critical for the timely market introduction of BDPS products with complex regulatory requirements.* Responsible for managing regulatory activities within a world wide business, and for continued interaction between the business, agents of the US Food and Drug Administration, and agents of Health Ministries of non-US countries.* Supervises Regulatory Affairs personnel capable of developing strategies to obtain appropriate regulatory clearances, and assessing the type and amount of product performance data required, ensuring timely product approval.* Manage regulatory information by organizing the regulatory awareness on any new regulation that may impact BDM-PS products. Maintain the knowledge and awareness of current applicable regulations and standards.* Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assess potential impacts to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.* Support to customers for regulatory advice and registration of their products.* Regulatory impact assessment of changes in coordination with Change Control Group* Participates on multiple cross-functional teams within BDPS.* Independently manage multiple projects and meet required milestones.QualificationsMinimum of 5 years of WW Regulatory ExperienceExperience managing and developing a teamExperience in Medicinal Product and Medical Device Regulatory AffairsExperience and knowledge in quality systems and quality management

Job Title: Senior Program Manager of Regulatory Affairs Company: Kforce Clinical Research Staffing Location: Nutley, NJ Description: .mainbody .RightColumn .LeftColumn a .jlocation .jdetail .jtitle .jdescription .jFontstyle14 .jFontstats .jFontstyle13 .jFontstyle16 .jFontstyle17 .position .jFontstats Status: Full-Time, Employee Level: 2-5 Years Experience Job Location: Nutley, NJ Job Ref Code: OTNRC971214 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About Kforce Clinical Research . . . . . . . . . . . . . Kforce Clinical Research offers more than 20 years of experience with a strong commitment to providing exceptional service by building great teams dedicated to operational excellence. Kforces long-term client relationships open the door to rewarding opportunities, giving candidates access to the worlds top biopharmaceutical companies. In addition to providing exciting opportunities, our Firm takes the time to get to know each candidates career aspirations, enabling Kforce to be their career advocate. Our clinical research specialty areas include: monitoring/site management, study management, regulatory affairs, drug safety, data management, data entry, clinical programming, biostatistics and quality assurance. Backed by approximately 1,900 staffing specialists, Kforce is committed to "Great People = Great Results" for our valued clients and candidates. Our Firm operates with 62 offices in 41 markets in North America and two in the Philippines. Kforce is an EEO/AA Employer . POSITION Senior Program Manager of Regulatory Affairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Job Description: At Kforce Clinical Research, we don't just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the world's most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Senior Program Manager of Regulatory Affairs in Nutley, NJ. Specific Accountabilities: Provide U.S. regulatory strategic direction as the U.S. regulatory lead of global teams and U.S. product teams for projects of moderate complexity and/or discrete components (line extensions and new indications) of larger projects of moderate complexityServe as the principal interface with primary reviewers from health authorities (FDA, etc.)Develop regulatory strategies, provide direction on health authority interactions, prepare regulatory submissions and demonstrates leadership on the team and within the function to accomplish business objectivesCoordinate activities of small groups of local personnel to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelinesManage special regulatory projects of moderate complexity, as assigned by othersDue to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Requirements Include: 3-5 years of relevant experience in drug development including relevant experience in regulatory affairsBachelor's DegreeBasic working knowledge of core processes: discovery, development, manufacturing and marketingDemonstrated leadership skillsCommunication and organizational skillsExcellent team and interpersonal skillsCommitment to performance measures of time, costs, and qualityKforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!Apply for this job Great People = Great Results

Job Title: Executive Director, Regulatory Affairs Company: Forest Laboratories, Inc. Location: Jersey City, NJ Description: Within therapeutic areas of responsibility: -Coordinates interaction of his/her direct reports with regulatory agencies. Provides support to staff in communications with agencies. Has established relationships with agencies. Maintains corporate credibility with agency officials. -Maintain a vigilance of proposed changes and new regulatory legislation. Evaluate the impact of proposed changes and devise strategies and to ensure efficient regulatory functions. Provide regulatory assessments and conducts regulatory due diligence for new opportunities -Insure optimal acceptable regulatory strategies for worldwide compliance and submissions, from development through marketing, including advertising, promotion, and labeling, in an environment committed to the efficient and aggressive development of new drugs for patients -Develop and implement regulatory strategies for new products, product improvements, new indications; -Champion regulatory activities throughout Forest Laboratories. Proactively integrate with preclinical, clin/pharm, clinical development, commercial (marketing), and manufacturing programs to provide regulatory strategy and direction that will accomplish results for worldwide registrations and regulatory product maintenance activities in a positive manner. -Help manage and participate in the processes to achieve regulatory agency input into research and development programs. -Communicate and negotiate all activities pertaining to his/her assigned therapeutic areas with applicable regulatory agencies to ensure efficient drug development and drug approvals. -Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs. -Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions. -Performance management of regulatory therapeutic areas and direct reports -Establish, manage, and mentor therapeutic area team. -As a member of Regulatory Affairs management team, evaluate functional strengths and developmental areas of the department. Identify and recommend solutions to improve departmental efficiency and effectiveness. -Maintain a high level of expertise through reading and attendance at professional seminars, workshops. -Exercises outstanding judgment in all areas of responsibility. -Maintain fiscal responsibility for department operations and product Education, Licensure & Certifications: -Advanced Science Degree with a concentration in healthcare or sciences is required. -Regulatory Affairs Certification (RAC) preferred Required Experience: -Demonstrated Regulatory, Quality & Compliance professional with a minimum of 10 years of Pharma / Bio-Pharma experience. -Track record of NDA approvals and with contributions to the approval of new products. -Extensive experience successfully interacting with regulatory authorities; strong existing relationship with key regulatory agencies -Experience with US and International agencies (Europe, Asia, Japan, and South America) -A strong understanding of the interface between clinical development and preclinical research. -Demonstrated leadership and management capabilities -Strong management and leadership skills along with strategic thinking ability. Technical Qualifications: -Knowledge of all relevant pharma regulatory procedures and reporting requirements -Experience with document management of INDs, IND Amendments, FDA Briefing Packages, and NDAs. -Experience with CTD /e-CTD preparation preferred. -Strong technical background including proficiency in Windows, Microsoft Office, and Documentum. General Qualifications: -Energetic, self-motivated, hands on manager; and efficient multi-tasker who is accustomed to working in deadline-focused, high-pressure entrepreneurial environment. -Ability to manage multiple simultaneous products/projects. -Articulate -- comfortable in both written and oral communications and presentations -Provides strategic leadership by determining opportunities and threats through comprehensive analysis of current and future trends. -Demonstrates consistent logic, rationality, and objectivity when identifying significant problems and opportunities. -Creative problem solver with the ability to establish systems and define standard practices. -Displays high level of integrity by remaining consistent in terms of what he/she says and does in terms of behavior toward others. -Proven track record of establishing, managing, and mentoring cross-functional project teams of technical resources. -Fosters high levels of accountability through fair, hard-hitting performance-management system. Measures performance thoroughly. -Willing team player capable of working collaboratively with colleagues in their department and in all functions -High degree of presence and authority without arrogance; represents the department, company, and partnerships with professionalism and credibility. Strong predisposition toward customer service.

Job Title: NJ - Regulatory Affairs Manager Company: B2BSalesPros.com Location: New Brunswick, NJ Description: NJ - Regulatory Affairs Manager Oct 17, 2007Bridgewater, New JerseyReturn to Search Results|Send job to a friendDescription:Spectacular Opportunity to Work for Leading Oncology Pharmaceutical Company!Oncology pharmaceutical company searching for qualified Regulatory Affairs Manager! Candidatemust haveexperience producing quality product applications for marketing approval of products, thorough knowledge of DDMAC, and have oncology background! The ideal candidate will be currently working in the Regulatory Dept. in Pharm.Great pay for "the right" person!!! Interviews Immediately!

Job Title: Director Regulatory Affairs Company: Merck-Legacy Schering Plough Location: Roseland, NJ Description: Employer Information About Merck-Legacy Schering Plough Merck-Legacy Schering Plough View all our jobs