Manager Of Regulatory Affairs Jobs in New Jersey

Job Title: Manager/Associate Director Regulatory Affairs - Pharmaceutical Drug Regulatory Affairs- Reg Affairs Company: CyberCoders Location: Florham Park, NJ Description: Manager/Associate Director Regulatory Affairs - Pharmaceutical Drug Regulatory Affairs- Reg Affairs Manager/Associate Director Regulatory Affairs - Pharmaceutical Drug Regulatory Affairs- Reg Affairs near Morristown, NJ This job is open as of 7/20/2010. Apply Now! Not a fit for this job? Search other Manager/Associate Director Regulatory Affairs jobs! Are you an employer? Visit us for more info! Email this job to a friend - $1000 Location Morristown, NJ; Florham Park, NJ Salary $85,000 - $150,000 Education Bachelor of Science Category Research Experience Required At least 2 Years Short Description Manager/Associate Director Regulatory Affairs - Pharmaceutical Drug Regulatory Affairs- Reg Affairs Required Skills Pharmaceutical, Manager/Associate Director Regulatory Affairs, Regulatory Strategy, CNS, FDA, IND, NDA, EU, DDMAC, Regulatory Guidance Documents Recruiter Erin Beagle Date Updated 7/20/2010 Skills Required Pharmaceutical, Manager/Associate Director Regulatory Affairs, Regulatory Strategy, CNS, FDA, IND, NDA, EU, DDMAC, Regulatory Guidance Documents Job Description Manager/Associate Director Regulatory Affairs - Pharmaceutical If you are a Sr Regulatory Specialist, Manager, or Associate Director of Regulatory Affairs with CNS experience who has filed IND's and NDA's to EU and US authorities, please read on! What you need for this position: -Advanced degree highly preferred! -6-8 years of regulatory experience -IND, NDA filing experience -Interaction with DDMAC is desired What you'll be doing: -Acting as the core regulatory representative for CNS products -Service as the primary contact person with the FDA -Monitoring CNS programs -Developing and leading the global regulatory strategy for assigned products What's in it for you: -Excellent compensation, bonus, benefits -Opportunity for advancement in this very stable pharmaceutical company So, if you are a Sr Regulatory Specialist, Manager, or Associate Director of Regulatory Affairs with CNS experience who has filed IND's and NDA's to EU and US authorities, 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-MgrADRegulatoryAffairs -- in the email subject line for your application to be considered.*** Erin Beagle - Executive Recruiter - CyberCoders Other Jobs

Job Title: Associate Director, Regulatory Affairs Company: Celgene Corporation Location: Basking Ridge, NJ Description: Prerequisites: Completed BA/BS degree in scientific discipline required; Must have 5-9 years professional working experience in the pharmaceutical industry, including 3-5 years regulatory affairs experience; Must have experience in multiple phases of development in various therapeutic areas; Completed advanced degree preferred (such as MA/MS, PhD, etc.) preferred; Global experience desirable; and Experience in inflammatory and immune diseases a plus.SummaryResponsibilities will include, but are not limited to, the following:1. Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.2. Lead global and/or regional regulatory team on assigned projects.3. Develop and execute US regulatory strategy and contingencies for assigned projects.4. Serve as the primary interface for FDA on assigned projects.5. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned. 6. Prepare company team for FDA and other health agency meetings, as required.7. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.8. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.9. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.10. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.Skills/Knowledge Required: Completed BA/BS degree in scientific discipline required. Must have 5-9 years professional working experience in the pharmaceutical industry, including 3-5 years regulatory affairs experience. Must have experience in multiple phases of development in various therapeutic areas. Thorough knowledge of the drug development process, IND and NDA process. Demonstrated experience in preparing FDA submissions. Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy. Inter-dependant partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail. Domestic and occasional International travel may be necessary.Preferred Skills/Knowledge Required: Completed advanced degree preferred (such as MA/MS, PhD, etc.). Global experience desirable. Experience in inflammatory and immune diseases a plus.Apply at www.celgene.com/careers/pharmaceutical-us-job-openings.aspx or visit our website to view all of our open positions at www.celgene.com.Celgene Corporation is an equal opportunity employer.

Job Title: Associate Director - Regulatory Affairs Company: Wyeth Location: Madison, NJ Description: At Wyeth, we have a vision of leading the way to a healthier world. We've ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.Job SummaryPrimary responsibility will be the global coordination of regulatory activities for medical devices. Reporting to the Director, New Drugs and Devices, the candidate will be responsible for developing and coordinating global regulatory strategies, along with oversight of US regulatory activities. The candidate may also be assigned responsibility for OTC drug or cosmetic products.Job ResponsibilitiesGlobal Regulatory: Develop and coordinate implementation of global regulatory strategiesUS Regulatory: Interfaces directly with FDA regulatory personnel including scientific reviewers, administrative staff and management to facilitate the review and approval of regulatory applications, including the planning and conduct of formal meetings and teleconferences with regulatory authorities. GRA representation on drug/ medical device project teams US FDA regulatory liaisonCommunication of regulatory status and/or issues to GRA management and PDTsIdentification of regulatory strategic options for drugs/ medical device productsBasic QualificationPreferred BS degree in sciences or equivalent and 11 12 years experience in a FDA-regulated environment MS/Pharm D or equivalent and 8 9 years in FDA-regulated environment.PhD or equivalent and 5 6 years in FDA-regulated environment.Experience in a project team environment including coordination and preparation of 510(k), PMA, IDE, INDs, NDAs, BLA supplements and product correspondence is strongly desired. Also, a familiarity with GMPs, specifically 21 CFR parts 200, 300, and 600 is a plus.Relocation is not available for this position.Wyeth offers and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.

Job Title: Regulatory Affairs Director Company: Hess Corporation Location: Woodbridge, NJ Description: Facilitate Hess business strategies by optimizing natural gas competitive markets, and minimizing program costs, through interactions with both regulatory agencies and public utilities- Identify opportunities and contribute to Hess strategic efforts- Coordinate with gas operations personnel to address issues of concern and develop strategy for participation in regulatory proceedings- Oversee and direct outside counsel and consultants as necessary -Participate in industry groups and strive to direct the group to adopt and promote Hess positionResponsibilities- Establish and cultivate strong relationships with regulatory staff and commissioners at state public utility commissions- Maintain thorough knowledge of existing and proposed regulations, rules and procedures, and influence outcomes- Represent Hess interests in state regulatory agency proceedings as well as informal meetings and working groups- Monitor pending and existing regulatory activities that will affect growth opportunities in the competitive markets Hess is pursuing, or Hess cost of doingbusiness in existing markets- Ensure compliance with state regulatory requirements related to marketing natural gas- Interact with utilities on tariff and/or contract matters to minimize Hess operational costs and optimize growth opportunities- Coordinate all regulatory efforts with Hess market development strategies- Communicate effectively with company personnel on any developments regarding the state of the competitive markets in the various jurisdictions- Manage the development and implementation of specific company plans for interactions with both utilities and regulatory agencies- Prepare and maintain annual budgets for the Natural Gas Regulatory Group

Job Title: Associate Director, Regulatory Affairs Company: TEVA Pharmaceuticals USA Location: Woodcliff Lake, NJ Description: Teva Pharmaceuticals USA is the leading generic pharmaceutical company, marketing products from a wide range of therapeutic areas including analgesic, anti-infective, cardiovascular, oncology, CNS, dermatological and anti-inflammatory. Teva USA products are marketed to chains, wholesalers, distributors, hospitals, managed care entities, and government agencies. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. TEVA Pharmaceuticals USA has the following employment opportunity in their Woodcliff Lake, NJ location. Responsibilities: Position SummaryThe Associate Director, Regulatory Affairs in partnership with the Director & VP of Regulatory Affairs, will help develop regulatory strategy and be an active partner in project planning and execution. The Associate Director will provide sound and timely advice on regulatory activities such as the coordination and development of regulatory submissions. The Associate Director will manage the technical regulatory unit ensuring consistent application of law, regulation and guidance across regulatory projects. This candidate critically reviews internal documents and regulatory submissions to FDA and is responsible for ensuring that project deadlines and performance standards are established and met.Essential Duties:Review outgoing FDA correspondence (ANDAs, amendments, supplements) for completeness, correctness and compliance to FDA regulations and guidelines.Assist in the development and communication of and facilitate proper implementation of regulatory strategies to Development and Operations professional staff on product specific issues.Review and approve internal change control documentation.Review incoming FDA correspondence and collaborate in the determination of required elements for response.Direct FDA Contact (via telephone)Interpret for the Regulatory Affairs department and other departments, as appropriate, the impact of new FDA guidelines, policies, regulations, etc. and conduct training, as needed.Responsible for creation and maintenance of training manual for RA Employees. Also responsible for the training of new RA EmployeesProvide input, as needed, on technically challenging projectsReview and provide comments to Director or VP regarding documents disseminated by GPHAInterface with R&D group regarding complex development issues and associated regulatory strategy.Follow Teva Safety, Health, and Environmental policies and procedures.Other duties, as assigned, or as business needs require.Primary Outcomes:On time submission of and approval of ANDAs and supplements; maintain approved ANDAs in compliance with FDA regulations; provide appropriate regulatory guidance to research and operations professional staff. Supervise/train regulatory professional staff to improve their knowledge and performance Qualifications: Position RequirementsEducation Required:Minimum BS degree in scientific or healthcare discipline or equivalent combination of education and related experience.Education PreferredR. Ph. or Pharm.D. MS or Ph.D. in scientific or healthcare discipline or equivalent combination of education and related experience.Experience Required:Minimum 5 years in pharmaceutical regulatory affairs, with an emphasis on CMC.Specialized or Technical Knowledge Licenses, Certifications needed:RAC certification beneficial, but not required; working knowledge of chemistry, manufacturing and controls, as needed for ANDA submissions. Prior pharmaceutical experience involving chemistry or manufacturing.Job-specific Competencies TechnicalDemonstrates a thorough understanding of ICH and FDA guidelinesDemonstrates strong understanding of R&D processes required for ANDA submissions.Problem SolvingDemonstrates higher ability to negotiate response to FDA deficiencies in a manner acceptable to both FDA and affected Teva departmentsDemonstrates advanced judgment in determining whether an ANDA is sufficiently complete to be accepted for filing by OGD, or whether it will be refused.InterpersonalDemonstrates strong ability to establish sound professional relationships with other Teva departments and Government employees.CommunicationDemonstrates excellent oral and written communication skills, including editing of documents prepared by others.Autonomy & IndependenceDemonstrates a higher ability to make appropriate decisions, prioritizations and to determine if an issue needs to be elevated to upper management.

Job Title: Manager, Regulatory Affairs Company: Eisai Inc. Location: Woodcliff Lake, NJ Description: The incumbent will help to define, develop, and execute regulatory strategies in support of corporate drug development objectives. They will be responsible for lifecycle management of commercial and investigational drugs ensuring regulatory submissions are complied and submitted to authorities/agencies within defined time schedules, and in accordance with established company standards and protocols. They will continuously monitor the regulatory environment developing deep skills and content knowledge of clinical submissions and overall regulatory processes/requirements.Other responsibilities include (but are not limited to);Taking responsibility for the quality and completeness of regulatory submissions for Investigational and New Drug Applications, amendments, updates etc. Accountability for overall quality and compliance of regulatory submission documents to the appropriate regulatory bodies and acting as the day to day contact point with regulatory authorities for communications relating to proposed/pending applicationsProviding input into clinical and drug development plans for projects assignedWorking closely with Eisai colleagues to ensure that the regulatory strategy is addressed and any required submissions are made within the specified timeframesOrganizing Regulatory Agency meetings and accompanying briefing documents in accordance with project requirementsWorking closely with Eisai colleagues at ESI and other offices as well as CROs and Partner companies to ensure that correct and complete submissions are made within agreed timeframesProviding regulatory input into international project teams for the projects assignedAccountable for supervision and training of junior staff and personal career development (e.g., through training and conference attendance)

Job Title: Director, Regulatory Affairs: Rapidly Growing Pharmaceutical Company Company: Cornerstone Search Group, LLC Location: Ridgewood, NJ Description: Director, Regulatory Affairs: Rapidly Growing Pharmaceutical Company Our client, a rapidly growing pharmaceutical company, is looking for an experienced Regulatory Affairs/Operations professional. You will serve as a key member to submission management activities, while also overseeing many operational aspects of the regulatory affairs process. This is an entrepreneurial company that offers the best of both worlds (both big and small pharma) and is very competitive with compensation and benefits. Note: All inquiries and submissions are held in strict confidence (see our privacy policy below). Company Description: Our client is a rapidly growing pharmaceutical company that offers the best of both worlds. They offer an entrepreneurial atmosphere while also maintaining a very stable environment. Location: Northern, New Jersey Attractive features about this position and company: Visibility: Report directly to a very experienced Executive Director, Regulatory Affairs. Impact: The success of this Company's leading drug will hinge to a great degree on the regulatory affairs team. Opportunity: Join this company while it's still relatively small (i.e. ground floor). Successful Management Team: This Company has a management team with a proven track record in the Pharmaceutical Industry. Challenges, Expectations and Deliverables: Proactively provides timely strategic input and clearly communicate critical topics to project teams, vendors, and appropriate members of management to make quality regulatory decisions as necessary, balancing risks and benefits. Guide scientific writing for CMC, Clinical and Non-Clinical sections of INDs, NDAs, supplements, and amendments, and prepare CMC regulatory documents from technical departments in R&D and Operations for submission to Health Authorities. Primary liaison with FDA through written communication and participate in Agency meetings regarding regulatory issues. Direct the preparation (content) of submissions (INDs, IND amendments, CTAs, CTA amendments, BLAs and BLA supplements and periodic reports) to the Health Agencies. Responsible for coordination with Regulatory CROs for CTA activites if appropriate. Responsible for direct coordination /liaison between Health Agency representatives and function groups within company. Provide guidance to multifunctional development teams concerning strategic decisions and health authority interactions. Requirements: Bachelor's / Masters degree in life sciences. Advanced degree preferred 5+ years of regulatory affairs experience within the pharmaceutical industry. Submissions experience is required. Experience with INDs, NDAs, and BLAs. Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact: Steven Raz Managing Partner Register to View Cornerstone Search Group, LLC 6 Campus Drive Parsippany, NJ 07054 P Register to View x712 Web/URL: www.cornerstonesg.com About CORNERSTONE SEARCH GROUP Cornerstone is a Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in the heart of New Jersey's Pharmaceutical Corridor. Cornerstonepartners with Pharmaceutical, Biotechnology, and Consumer Healthcare companies to identify, attract and hire accomplished professionals from the Senior Staff through Executive levels that areinvolved in thediscovery, development, and commercialization of drugs and therapeutic treatments for the US and international markets. Cornerstoneoffers a comprehensive range of talent acquisition services including:Retained Search, Performance-Based Retained Search, Contingent Search (for full-time and consulting positions), and Strategic Advisory Services (e.g. organizational structure development, recruitment strategies, and compensation/benefit guidance). Cornerstone has a deep reservoir of industry knowledge andcontactsdue to our single industry focus, ahighly experienced management team committed toprofessional client service, andwe continuously invest in our people, processes, and technology. Cornerstonestrives every dayto meet and exceed our mission statement: 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.

Job Title: MANAGER, REGULATORY AFFAIRS Company: The Judge Group, Inc. Location: Matawan, NJ Description: Location: Princeton NJ Office based; ~15-20% US/International travel. The holder of this position assists Regulatory management in two key roles (1) providing Advertising and Promotional regulatory review support (DDMAC), and (2) serving as local Regulatory Affairs Project Leader for Latin America project. Responsible for the coordination, compilation and submission of filings in support of new indications of currently marketed and potential new products to the FDA and other global regulatory authorities, as requested and the maintenance of the records of those submissions. Education/Experience: Bachelors degree in Life Sciences and minimum of 5 years broad "hands on" Regulatory Affairs pharmaceutical experience with an emphasis on post-marketed NDA products. Advertising and Promotional experience a must. Spanish language skills at the business level due to interaction with Latin American customers....highly preferred Job ID: JO144675 Please refer to job code JO144675 when responding to this ad.

Job Title: Associate Director/Director - Regulatory Affairs Company: Eisai Inc. Location: Woodcliff Lake, NJ Description: The incumbent will be responsible for developing and guiding the global regulatory strategy for assigned products, and serve as the core global regulatory representative on International Project Teams for assigned products and provide regulatory leadership.Other responsibilities include (burt are not limited to):Supervising the preparation of global regulatory submissions, and serving as the primary contact person with FDA for assigned products.Monitoring programs (development projects and approved products) so they comply with the required Health Authority Regulations and Laws.Reviewing and approving protocols, reports, and documents used in regulatory submissions.Overseeing overall regulatory labeling function for assigned marketed products.Providing regulatory input into US strategic marketing initiatives and ESI policies regarding advertising and promotional activities.Reviewing and approving all advertising and promotional materials for assigned products to insure that they comply with FDA regulations, as well as serving as primary contact person for DDMAC.Developing, implementing and maintaining regulatory procedures regarding review of advertising and promotional materials for US marketed productsKeeping abreast of all pertinent laws, regulations and guidances as they pertain to regulatory strategies and submissions.

Job Title: Manager, Regulatory Affairs Company: Johnson & Johnson Location: Raritan, NJ Description: Ortho Clinical Diagnostics, a member of Johnson Johnsons Family of Companies, is recruiting for a Manager, Regulatory Affairs, located inRaritan, NJ. This position will support the Therakos, Inc. and Veridex, LLC. parts of the OCD franchise. Therakos, Inc. markets Extracorporeal photopheresis (ECP) systems that in the US are indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma that are unresponsive to other forms of treatment. THERAKOS Photopheresis has been used as a palliative therapy for CTCL for over 20 years, in over 500,000 treatments. Extracorporeal photopheresis (ECP) is performed using either the THERAKOS CELLEX Photopheresis System or the THERAKOS UVAR XTS Photopheresis System.Veridex, LLC is an organization dedicated to providing physicians with high-value in vitro diagnostic oncology products. Veridex products may significantly benefit patients through earlier disease detection and may enable personalized strategies to help improve patient management and outcomes. Veridex markets the CellSearch Circulating Tumor Cell (CTC) Test, a simple blood test that captures and assesses CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer.The Manager, Regulatory Affairs will be responsible for IND clinical trials supporting new indications for THERAKOS Photopheresis, which is a combination product (NDA/PMA), and for providing regulatory support to both organizations. The Manager will interpret regulatory requirements and determine strategy to obtain appropriate registrations, and will prepare complex FDA for assigned projects consistent with established regulatory policies. The role will provide guidance and leadership to RD, Clinical, and Operations for the preparation of assigned regulatory submissions in compliance with global regulatory requirements. Thisroleincludes review of information during development for accuracy,soundness and adherence to regulatory requirements.The Manager, Regulatory Affairs will officially represent the companies to domestic and foreign regulatory agencies and will interact extensively with senior level FDA personnel in order to expedite approval of pending applications, resolve regulatory matters and manage development meetings for regulatory submissions.Will represent Regulatory during facilities audit / inspections support (e.g. ISO, FDA, etc.);SME for regulatory status of products.Advises leadership concerning proposed regulations; provides guidance in interpretation, impact to company. The Manager, Regulatory Affairs will facilitate integration of government and Corporate regulatory policies in strategic planning and operations.